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Approximately 20 percent of corneal transplant patients, about 6,000 per year, face donor tissue rejection at rates of up to 60 percent because of corneal vascularization or prior graft rejection. Histocompatibility antigen matching and/or crossmatching may have offered these patients an improved chance for successful ... | To determine whether histocompatibility matching of corneal transplant donors and recipients can reduce the incidence of graft rejection in high-risk patients. |
BACKGROUND:~Infection remains a major cause of death in patients receiving chemotherapy for malignant diseases. One approach to the problem of septicemia and high mortality in these patients was the therapeutic use of granulocyte transfusions. Improvements in collection techniques, employing continuous flow centrifugat... | To evaluate granulocyte transfusion therapy with respect to its prophylactic and therapeutic effectiveness to prevent and aid recovery from infection. The study trials were conducted simultaneously. |
Renal transplantation is recognized as the treatment of choice for children with chronic renal failure. However, patient and graft survival rates in young children are unacceptably low. In preliminary studies, OKT3 (a monoclonal antibody) induction therapy received post transplant has been more successful than standard... | Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is... |
NMR imaging promises to provide useful and unique diagnostic information in a variety of diseases. In an attempt to evaluate its role, we plan to study a wide range of diseases during the initial year of imaging. Exposure to magnetic fields and radiofrequency energies of this magnitude have demonstrated no deleterious ... | This protocol is designed to investigate the use of novel techniques in MRI that may not yet be commercially available. Specifically, the protocol enables patients to take advantage of new pulse sequence software, coil design or post processing capabilities not otherwise available. The informed consent explains MRI in ... |
Background:~It may be in the interest of the CCR to continue to follow and treat certain subjects after they have completed their treatment and participation on a research protocol.~Objective:~To provide continuing treatment and medical follow-up for CCR subjects who have completed their treatment and participation on ... | This protocol is to provide continuing medical/surgical/radio-therapeutic care, treatment and follow-up for NCI patients not currently entered on an active research protocol. No investigational treatments will be administered on this protocol. |
Objective:~Our goal is to study the functional organization of the intact human brain by combining cognitive tasks and neuroimaging. Functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG) and electroencephalography (EEG) will be used to measure brain activity in healthy human subjects engaged in per... | The purpose of this study is to use brain imaging technology to measure changes in blood flow to areas in the brain as individuals perform intellectual tasks.~This study will use functional magnetic resonance imaging (fMRI) to examine blood flow to areas of the brain as participants engage in tasks associated with visu... |
The MTD and biochemically active dose of FUDR as a 24-hour and gemcitabine as a 2-hour infusion will be determined first (Part A); if the biochemically active FUDR dose is less than the MTD, new patients will be entered to determine the maximum tolerated duration of FUDR infusion (Part B). | The purpose of this study is to determine the clinical toxicities associated with administering sequential dFdC as a one hour infusion followed by a continuous infusion of FUdR over 24 hours with low dose oral LV weekly for three weeks out of four. |
The National Marrow Donor Program (NMDP) was established in 1987 in order to (1) create a registry of volunteer, prospectively tissue-typed, unrelated bone marrow donors, (2) facilitate the performance of matched unrelated donor marrow transplants through a coordinated circuit of Donor Centers, Collection Centers and T... | Individuals interested in becoming prospective bone marrow donors and joining the Registry of the National Marrow Donor Program (NMDP) should do so by calling 301-496-0572, the phone number of the NIH Marrow Donor Center. An appointment will be made to have a health history taken and to have a buccal swab collected for... |
Background:~Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.~Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigator... | This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol. |
Acquisition of fresh tumor and normal tissue samples is necessary for the preparation of cDNA libraries, microarray chips, tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of patient samples at the time of tissue sampling for surgery, diagnostic tests, or therapeut... | Acquisition of fresh tumor and normal tissue samples are necessary for the preparation of cDNA libraries, microarray chips, and tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic ... |
This study will examine the role of temperature in modulating aspects of energy metabolism in human skeletal muscle. Tests will be conducted at rest and during concentric dorsiflexion exercise of the Tibialis anterior (TA) muscle using an existing custom-designed dynamometer in conjunction with mild local heating and c... | This study will examine the role of temperature in changing energy metabolism in human muscle. In order to do this, researchers will use magnetic resonance imaging (MRI) to provide information about how parts of muscle operate during exercise.~Magnetic resonance imaging (MRI) is a diagnostic tool that creates high qual... |
Proper functioning of recently acquired P-CCMB cardiopulmonary exercise equipment will be verified by testing healthy volunteers. In addition, quality control will be verified by performing monthly testing of healthy volunteers as biologic standards. | This study is designed to make sure exercise equipment used by the National Heart, Lung, and Blood Institute is working properly. Healthy volunteers will be requested to use P-CCMB cardiopulmonary exercise equipment (treadmills and exercise bicycles) two times a month to ensure the machines are functioning properly. |
OBJECTIVES: I. Evaluate the clinical feasibility and toxicity of monoclonal antibody OKT3 given with low-dose cyclophosphamide in patients with advanced malignancies. II. Perform serial immune monitoring on patients treated with this regimen. III. Identify any clinical responses produced by this regimen.~OUTLINE: Biolo... | RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.~PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody and cyclophosphamide in treating patients with metastatic cancer. |
OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Ass... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.~PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting o... |
OBJECTIVES:~I. Determine the maximum tolerated dose and quantitative and qualitative toxic effects of topotecan and paclitaxel in patients with solid tumors.~II. Determine the antitumor activity of this regimen in these patients.~OUTLINE: This is a dose escalation study of topotecan and paclitaxel.~Patients receive pac... | Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. |
OBJECTIVES: I. Determine the biochemical modulation dose l of O6-benzylguanine (BG), defined as the dose at which baseline O6-alkylguanine DNA alkyltransferase (AGT) activity in circulating peripheral blood mononuclear cells (PBMC) decreases by greater than 90% in patients with advanced solid tumors at 2 hours after BG... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine and carmustine in treating patients who have solid tumors. |
OBJECTIVES: I. Determine whether adoptive immunotherapy comprising donor-derived CD8+, CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones is effective in preventing CMV viremia and disease i... | RATIONALE: White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation.~PURPOSE: Phase II trial to study the effectiveness of donated white blood cells to prevent cytom... |
OBJECTIVES: I. Determine the complete histologic response rate (which represents the rate of organ preservation) to induction with cisplatin/fluorouracil followed by radiotherapy plus cisplatin in patients with selected stage III/IV cancer of the hypopharynx or base of the tongue. II. Evaluate the feasibility of accrui... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.~PURPOSE: Phase II trial to study the effect... |
OBJECTIVES:~Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell support, to patients with advanced carcinomas.... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of combination chemoth... |
OBJECTIVES: I. Determine the maximum tolerated dose of ICI D1694 (TDX) when given with irinotecan (CPT-11) every 3 weeks in patients with advanced solid malignancies. II. Describe the pharmacokinetics of TDX and CPT-11 when given in combination. III. Investigate the relationship between topoisomerase I expression in pe... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating patients with advanced solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of KRN5500 in patients with solid malignant tumors. II. Characterize the clinical pharmacokinetics of KRN5500 in this patient population. III. Initiate the preliminary evaluation of antitumor activity of KRN5500 in these patients. IV. Determine the reco... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to evaluate the effectiveness of KRN5500 in treating patients with metastatic solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies. II. Evaluate the toxicity and safety of this combination regimen in this patient population. III. Determine the pharmacokinetic profile of irinotecan... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer. |
OBJECTIVES:~Determine the maximum tolerated dose, toxicities, and preliminary antitumor activity of escalating doses of topotecan, with filgrastim (G-CSF) and peripheral blood stem cell support, when administered to patients with refractory malignancies for which no effective therapy exists.~OUTLINE: This is a dose-esc... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of drugs and kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of high... |
OBJECTIVES: I. Identify a priming schedule of sargramostim (GM-CSF) that reduces the percentage of progenitor cells in cycle at the time of chemotherapy administration in patients with advanced malignancies. II. Determine the maximum tolerated dose and toxic effects of topotecan when administered with sargramostim in t... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of ... |
OBJECTIVES: I. Determine whether morphine injected at the site of surgery can control pain from surgery.~OUTLINE: This is a prospective, double blind, randomized study. Patients are randomized into 3 groups with 6 patients in each group. Group 1 receives morphine diluted in normal saline (NS), which is administered in ... | RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief.~PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder i... |
OBJECTIVES: I. Define the safe and tolerance of an inhaled interleukin-2 (IL-2) administered once or twice a day. II. Determine blood levels of IL-2 and whether there is detectable stimulation of immune cells in patients receiving inhalation IL-2. III. Determine whether there is any shrinkage of pulmonary lesions of pa... | RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Giving interleukin-2 in different ways may kill more cancer cells.~PURPOSE: Phase I trial to study the effectiveness of inhaled interleukin-2 in treating patients with metastatic or unresectable cancer. |
OBJECTIVES: I. Determine the maximum tolerated dose of bizelesin in patients with advanced cancer. II. Determine the qualitative and quantitative toxic effects of this therapy in these patients. III. Determine the pharmacokinetics of this therapy in these patients. IV. Determine the recommended dose of this drug for ph... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of bizelesin in treating patients who have advanced cancer. |
OBJECTIVES:~Determine whether there is a relationship between pharmacokinetic measurements of paclitaxel and aging.~Determine whether there is a relationship between the toxic effects of paclitaxel and aging.~OUTLINE: Patients are stratified according to age (cohort 1: patients 55 to 64 vs cohort 2: patients 65 to 75 v... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors. |
OBJECTIVES: I. Determine the effect of varying the dietary intake of soy nuts on plasma levels and urinary excretion of isoflavones. II. Determine the effects of different food composition, along with age and gender of subjects, on plasma levels and urinary excretion of isoflavones.~OUTLINE: This is a two part study. I... | RATIONALE: Eating a diet rich in soy foods appears to reduce the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent the development of cancer.~PURPOSE: Clinical trial to determine the most effective amount and type of soy isoflavones needed in the diets of healthy men and women t... |
OBJECTIVES: I. Determine the dose limiting toxicity and maximum tolerated dose of combination bryostatin 1 and cisplatin chemotherapy in patients with advanced, incurable solid tumors.~OUTLINE: This is a dose-escalation study. The first 4 cohorts of patients receive an escalating dose of cisplatin with a fixed dose of ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of cisplatin plus bryostatin 1 in treating patients who have advanced cancer. |
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan in combination with raltitrexed in patients with refractory solid tumors. II. Describe and quantify the toxic effects of this combination treatment regimen in a minimally pretreated patient population. III. Determine the pharmacokinetics of this combinat... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of irinotecan plus raltitrexed in treating patients who have refractory solid tumors that have... |
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of bryostatin 1 in combination with cisplatin in patients with advanced malignancy. II. Determine the recommended phase II doses of bryostatin 1 and cisplatin in both a 21 day and 14 day course, based on toxicity, effect on protein kinase C ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus cisplatin in treating patients who have metastatic or unresectable cancer... |
OBJECTIVES: I. Determine the maximum tolerated doses and sequence of topotecan and ifosfamide that can be administered daily for 3 days on an every 4 week schedule in patients with refractory solid tumors. II. Evaluate toxicity of topotecan and ifosfamide when administered on this schedule in this patient population. I... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of chemotherapy with ifosfamide and topotecan in treating patients with refractory solid tumor... |
OBJECTIVES:~I. Determine the maximum tolerated dose of carboxyamidotriazole (CAI) in combination with ketoconazole in patients with advanced malignancies.~II. Evaluate the toxic effects, safety, and efficacy of CAI in combination with ketoconazole.~III. Determine the modulatory effects of ketoconazole on the pharmacoki... | Phase I trial to study the effectiveness of carboxyamidotriazole and ketoconazole in treating patients with advanced cancers. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. |
OBJECTIVES: I. Determine the maximum tolerated dose and toxicity of oral fenretinide in patients with solid malignant tumors. II. Determine the pharmacokinetics of fenretinide and its metabolites. III. Determine the preliminary antitumor activity of fenretinide in this patient population. IV. Determine the recommended ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating patients who have solid tumors. |
PRIMARY OBJECTIVES:~I. Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors.~II. Determine the toxic effects of EF5 in this patient population. III. Determine the pharmacokinetics of EF5 in this patient population. IV.... | Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery |
OBJECTIVES:~I. Determine the toxicity profile and maximum tolerated dose (MTD) of intravenous interleukin-12 (IL-12) administered biweekly for 6-18 weeks in the presence and absence of a test dose in patients with metastatic or unresectable malignancies.~II. Determine the optimal timing for administration of an IL-12 t... | Phase I trial to study the effectiveness of interleukin-12 in treating patients who have advanced cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. |
OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to patients with advanced refractory cancer on a 28-day schedule and establish a dose for further study. II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these patients. III. Determine the pharmacokinetic para... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of T138067 sodium in treating patients with advanced refractory cancer. |
OBJECTIVES: I. Determine the feasibility of administering multiple courses of chemotherapy without excessive dose modification or treatment delay in patients with previously untreated ovarian epithelial carcinoma or primary peritoneal carcinoma. II. Determine the response rate (in patients with measurable disease) and ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients with previously untreated stage III or stage ... |
OBJECTIVES: I. Determine the maximum tolerated dose of GPX-100 in outpatients with incurable, solid tumors who are not candidates for effective systemic therapy. II. Evaluate and quantify the toxicity of GPX-100 in this patient population. III. Identify any changes in disease status in this patient population.~OUTLINE:... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have solid tumors. |
OBJECTIVES:~I. Assess the safety and maximum tolerated dose of recombinant human interleukin-12 (rhIL-12) administered by intraperitoneal infusion in patients with chemotherapy refractory advanced ovarian cancer and other diffuse abdominal carcinomatosis.~II. Determine the immunopharmacologic profile of rhIL-12 in this... | Phase I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer cells. |
Recurrent or Stage IV Lung Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.~OBJECTIVES:~To determine the effica... | Current therapies for Recurrent or Stage IV Lung Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Recurrent or Stage IV Lung Cancer.~PURPOSE: This study is being performed to determine the effects (good and ... |
Cancer of Unknown Primary Origin patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.~OBJECTIVES:~To determine the efficac... | Current therapies for Cancer of Unknown Primary Origin provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Cancer of Unknown Primary Origin.~PURPOSE: This study is being performed to determine the effects (good and ba... |
OBJECTIVES: I. Determine the qualitative and quantitative toxicities of intraperitoneal aminocamptothecin colloidal dispersion administered every 28 days in 6 applications over a 12 day period in patients with advanced cancer confined to the peritoneal cavity. II. Determine the maximum tolerated dose of aminocamptothec... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of aminocamptothecin in treating patients with advanced cancer of the peritoneal cavity. |
OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel following amifostine in patients with recurrent or refractory solid tumors. II. Assess tumor response rate and survival in these patients.~OUTLINE: This is a dose escalation study of paclitaxel. Patients receive amifostine IV over 5 minutes or les... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.~PURPOSE: Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with ami... |
OBJECTIVES: I. Determine whether theophylline will improve the dyspnea rating of patients with cancer who are short of breath and have evidence of respiratory muscle weakness. II. Determine whether this drug will improve the ability to perform daily activities in this group of patients. III. Determine whether this drug... | RATIONALE: Theophylline may help to relieve shortness of breath in patients who have cancer. It is not yet known whether theophylline is more effective than no further treatment for shortness of breath.~PURPOSE: Randomized phase III trial to determine the effectiveness of theophylline in treating shortness of breath in... |
OBJECTIVES: I. Evaluate the effectiveness of daily oral pilocarpine versus placebo in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks by comparing proportion of patients with at least one response during the 2 week period, time of first response, and duration of first response... | RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer therapy. It is not yet known whether pilocarpine is more effective than no further treatment for this condition.~PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have d... |
OBJECTIVES: I. Determine the maximum tolerated dose of SarCNU in patients with advanced solid malignancies. II. Determine the toxic effects of SarCNU in these patients. III. Characterize the pharmacokinetic profile of this regimen in these patients. IV. Determine any evidence of antineoplastic activity of this regimen ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of chemotherapy using sarCNU in patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended phase II dose, and safety of BMS-184476 in patients with advanced solid tumors. II. Determine the pharmacokinetic profile of BMS-184476 and its metabolites in these patients. III. Determine preliminary evidence of antitumor activit... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of BMS-184476 in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the toxic effects and maximum tolerated dose (MTD) of LY231514 in patients with metastatic or locally advanced solid tumors and varying degrees of renal function. II. Determine the recommended dose for LY231514 in this patient population. III. Examine the effects of renal dysfunction on the pha... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function.~PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally... |
OBJECTIVES:~Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer.~Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients.~Determine the efficacy of this regimen in patients with m... | RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.~PURPOSE: Phase I trial to study the effectiveness of combining R115777 with gemcitabine in treating patients with advanced cancer. |
OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting toxicity of temozolomide in patients with advanced solid malignancies. II. Characterize the single- and multiple-dose pharmacokinetics of temozolomide following oral administration in these patients. III. Determine antitumor ac... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose of LY231514 followed by irinotecan in patients with metastatic cancer. II. Determine the quantitative and qualitative toxicity of LY231514 in combination with irinotecan in these patients. III. Assess plasma pharmacokinetics in these patients treated with this regimen... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with pemetrexed disodium and irinotecan in treating patients who h... |
OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in these patients. III. Determine the principal and dose limiting toxicities of intoplicine in these patients, and determine the duration and ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of intoplicine in treating patients who have advanced or metastatic solid tumors. |
OBJECTIVES: I. Determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies.~OUTLINE: Patients receive oral thalidomide 4 times daily. Cyclophosphamide is administered IV over 1 hour once every 4 weeks, beginning on the same day as thalidom... | RATIONALE: Thalidomide may kill tumor cells by stopping the growth of new blood vessels to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more tumor cells.~PURPOSE: Phase II trial to study the effec... |
OBJECTIVES: I. Determine the maximum tolerated dose of combretastatin A4 phosphate when administered at single doses every 21 days in patients with advanced solid tumors. II. Determine both the toxicity and dose limiting toxicity of this regimen in these patients. III. Determine the plasma and urine pharmacokinetics of... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of combretastatin A4 phosphate in treating patients who have advanced solid tumors that have not responded to previous therapy. |
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors that are refractory or for which no standard therapy exists. II. Determine the quantitative toxic effects of SR-45023A in these patients. III. Assess the pharmacokinetic profile of SR-45023A in ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response and/o... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not respon... |
OBJECTIVES: I. Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on progression free survival, overall survival, safety, response, and CA-125 levels in patients with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer.~OUTLINE: This is a randomized, open label, multicenter ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill more tumor cells.~PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus carboplatin with or without... |
OBJECTIVES:~Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.~Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.~Evaluate the effectiveness of this treatment regimen in these patients.~OUTLINE: This is a dose escalation, multicenter... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the severity and duration of mucositis in children undergoing stem cell transplantation. II. Determine the safety of this regimen in these patients. III. Determine serum glutamine levels achieved during this regimen in these patients.~OUTL... | RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system in children who are undergoing stem cell transplantation.~PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in reducing inflammation of the mouth and digestive system in children who are u... |
OBJECTIVES: I. Determine the maximum tolerated dose of melphalan and thiopeta in patients with recurrent or refractory solid tumors. II. Evaluate the overall survival and response rate in these patients.~OUTLINE: This is a dose escalation study. Patients receive cyclophosphamide IV over 1 hour on day 1 and paclitaxel I... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.~PURPOSE: Phase I trial to stu... |
OBJECTIVES:~Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer.~Assess the toxicity of this combination regimen in this patient population.~Evaluate this regimen in terms of response rate, response duration, and overall sur... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have adv... |
OBJECTIVES:~Determine complete response rate in post-hematopoietic stem cell transplant patients with severe veno-occlusive disease of the liver treated with defibrotide.~Determine the minimal effective dose of this drug in these patients.~Assess toxicity and adverse side effects of this drug in these patients.~OUTLINE... | RATIONALE: Giving defibrotide may be an effective treatment for liver damage that may result following peripheral stem cell transplantation.~PURPOSE: This randomized phase II trial is studying defibrotide to see how well it works in treating patients with severe liver disease after undergoing peripheral stem cell trans... |
OBJECTIVES:~Determine the maximum tolerated dose for a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies.~Determine the toxic effects and dose-limiting toxicity of AAG in this patient population.~Determine the safe dose of AAG for a Phase II study.~Measure the p... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer. |
OBJECTIVES: I. Determine the safety and tolerability of VX-853 in combination with doxorubicin HCl liposome in patients with relapsed or incurable solid tumors. II. Obtain pharmacokinetic profiles for various dosages of VX-853 administered in combination with doxorubicin HCl liposome. III. Achieve whole blood concentra... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I/II trial to study the effectiveness of VX-853 in treating patients who have solid tumors who are receiving liposomal doxorubicin. |
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of SR-45023A and relate these to drug effects, if ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have locally advanced or metastatic solid tumors that have not responded to previous treatment. |
OBJECTIVES:~Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer.~OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. P... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment. |
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of gemcitabine and cisplatin in patients with metastatic or recurrent nonhematologic malignancies.~OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine IV on days 1 and 8, followed immediately by cisplatin IV over 2 hours ... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumor... |
OBJECTIVES:~Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer.~Access the pattern of toxicity of this drug regimen in this patient population.~Determine the objective response rate, duration of response, and overall survival in pati... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not re... |
OBJECTIVES:~Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer.~Determine the qualitative and quantitative toxicities of this regimen in these patients.~Determine the therapeutic response to this regimen in these patients.~Determine the relationship bet... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer. |
OBJECTIVES: I. Determine the effects of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) in patients with solid tumors by evaluating the safety and tolerability, maximum tolerated dose (MTD) and recommended dose for Phase II studies, pharmacokinetics, and tumor response.~OUTLINE: This is a dose escalation stud... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone in treating patients who have solid tumors that have not responded to previous treatment. |
OBJECTIVES: I. Determine the maximum tolerated dose and safety of intratumoral live, genetically modified Salmonella typhimurium (VNP20009) in patients with refractory, superficial solid tumors. II. Determine the efficacy of VNP20009 in these patients.~OUTLINE: This is a dose-escalation study. Patients receive intratum... | RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing.~PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced or metastatic solid tumors that have not responded to previous therapy. |
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of gemcitabine in combination with oxaliplatin in patients with advanced malignancies. II. Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients.~OUTLINE: This is a multicenter, dose escalation study of gemcitabin... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and gemcitabine in treating patients who have advanced cancer. |
OBJECTIVES: I. Determine if captopril can block or prevent lung injury in patients undergoing autologous bone marrow or stem cell transplantation following cyclophosphamide and total body radiotherapy or high dose chemotherapy. II. Determine a series of surrogate lung injury prediction markers for monitoring patients u... | RATIONALE: Captopril may protect the lungs from the side effects of bone marrow or stem cell transplantation.~PURPOSE: Randomized phase III trial to determine the effectiveness of captopril to lessen the side effects in patients who are undergoing bone marrow or stem cell transplantation following chemotherapy and radi... |
PROTOCOL OUTLINE:~The parents of 1 family with known Mondini dysplasia are screened for the disorder using temporal bone computerized tomography without contrast. This information is used to determine the mode of inheritance. | OBJECTIVES:~I. Determine the mode of inheritance of nonsyndromal Mondini inner ear dysplasia, an inner ear malformation causing deafness, vestibular dysfunction, and recurrent meningitis. |
PROTOCOL OUTLINE: Pituitary size and anatomy and growth hormone response are evaluated.~All patients undergo MRI of the pituitary fossa on day 1. On day 2, homozygous patients receive a slow infusion of normal saline with blood sampling every 10 minutes. | OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.~II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs. |
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and Phase II dose of endostatin in patients with advanced refractory solid tumors. II. Determine the qualitative and quantitative nature of the toxicities encountered with endostatin in this patient population. III. Evaluate the basic pharmacokinetics and metabo... | RATIONALE: Endostatin may stop the growth of solid tumors by stopping blood flow to the tumor.~PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have advanced refractory solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended phase II dose, and safety of BMS-214662 in patients with advanced solid tumors. II. Determine the pharmacokinetics of BMS-214662 in these patients. III. Assess the absolute oral bioavailability of BMS-214662 using a capsule and sin... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the safety, tolerance, and maximum tolerated dose of TG4010 in patients with MUC1 positive advanced cancer. II. Determine the biological and immunological effects of this regimen in this patient population.~OUTLINE: This is a dose escalation study. Patients receive TG4010 IM weekly for 4 weeks,... | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.~PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced cancer. |
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when combined with docetaxel in patients with advanced solid malignancies. II. Determine the dose limiting toxicity of this regimen in these patients. III. Assess any antitumor activity of this regimen in these patients.~OUTLINE: This is a dose escalatio... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicities, safety, and a recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in patients with advanced solid tumors. II. Evaluate the plasma pharmacokinetics of this drug in this patient population. III. Determine an... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have advanced solid tumors that have not responded to previous therapy. |
OBJECTIVES: I. Determine the feasibility of administering multiple courses of carboplatin and topotecan without excessive dose modification or course delay in patients with previously untreated ovarian epithelial or primary peritoneal carcinoma. II. Describe the response rate and progression-free interval in these pati... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have stage III or stage IV ovarian epithe... |
OBJECTIVES: I. Determine the antitumor activity of topotecan in patients with recurrent platinum sensitive ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this treatment regimen in these patients.~OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-3. Tre... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer. |
DESIGN NARRATIVE:~The study was a subproject within a Specialized Centers of Research (SCOR) in Transfusion Medicine. The experimental design was based on the study and analysis of several unique sets of data. One set consisted of abstracted patient data including ICD-9-CM diagnosis and procedure, DRG and red cell unit... | To develop and apply quantitative methods by which to measure and characterize blood transfusion practice in specific diagnoses and procedures; to open scientific communication about transfusion practice within and across institutions; and to develop simpler methods for estimating annual national blood collections and ... |
BACKGROUND:~Accumulating data indicate that 70 to 80 percent of adults infected with the hepatitis C virus (HCV) develop persistent infection that may be associated with chronic hepatitis, cirrhosis, hepatocellular carcinoma and end-stage liver disease. Despite these potential mortal outcomes, the progression is indole... | To identify a large cohort of children transfused in the decade prior to second-generation anti-hepatitis C virus (HCV) donor screening (1982-1992). This will not only identify cases for the study of persistent infection and chronic hepatitis in children, but will allow for the determination of the annualized risk of t... |
PRIMARY OBJECTIVES:~I. To determine the toxicity profile and MTD of low-dose SC IL-2 administered in conjunction with BIW regimen of IV rhIL-12.~II. To determine the antitumor effects of combination therapy with IV rhIL-12 and SC IL-2.~III. To determine the impact low-dose SC IL-2 has on the magnitude and duration of i... | Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating patients who have advanced solid tumors. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interleukin-2 may stimulate a person's white bl... |
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose, dose limiting toxicities, and safety of BMS-188787 in patients with nonhematologic malignancies. II. Determine the plasma pharmacokinetics of BMS-188797 in these patients. III. Describe any antitumor activity of this treatment in these p... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of BMS-188797 in treating patients who have advanced solid tumors that have not responded to previous treatment. |
OBJECTIVES: I. Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors. II. Determine the relationship between dose or plasma levels and the clinical safety profile and antitumor effects of this treatment regimen in terms of objective response, stabilization of disease, or progress... | RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.~PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors. |
BACKGROUND:~The study continued research previously funded as part of a National Research and Demonstration Center (NRDC) in Transfusion Medicine.~DESIGN NARRATIVE:~There were six components to the study. The first identified significant factors influencing regular blood donations by individuals with different donation... | To retain individuals as blood donors once they have entered the voluntary blood donation system and to increase the frequency of their donations. |
BACKGROUND:~In 1986, the Department of the Navy initiated the National Bone Marrow Donor Registry. Because the support of a National Bone Marrow Donor Registry was not very closely related to the Navy's primary missions, in 1989 the management of the contract for the program was transferred by the Congress from the Nav... | To serve as a focal point for bone-marrow research. |
OBJECTIVES:~Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.~Determine the qualitative and quantitative toxic effects of this drug in these patients.~Determine the pharmacokinetics of this drug in these patients.~Investigate the... | RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.~PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors. |
OBJECTIVES:~Determine the maximum tolerated dose of the combination of fenretinide, paclitaxel, and cisplatin in patients with advanced solid tumors.~Determine the effect of fenretinide on the pharmacokinetics of paclitaxel and cisplatin.~Assess the relationship between dose or plasma levels of fenretinide and the safe... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced solid tumo... |
OBJECTIVES:~I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.~II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.~III. Determine the antitumor activity of this treatme... | Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use... |
OBJECTIVES:~Determine the dose-limiting toxic effects of R115777 and topotecan in patients with advanced solid tumors.~Determine the maximum tolerated dose of this regimen in these patients.~Determine pharmacokinetic profiles of topotecan alone and in combination with R115777 in these patients.~Measure the inhibition o... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Determine the maximum tolerated dose of BMS-214662 in combination with paclitaxel in patients with advanced solid tumors. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this treatment regimen in this patient population. IV. Determine th... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of paclitaxel and BMS-214662 in treating patients who have advanced solid tumors. |
OBJECTIVES: I. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions. II. Compare the cost effectiveness of these diagnostic methods in these patients. III. Demonstrate that radioactive ... | RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is not yet known which type of breast biopsy is more effective for diagnosing breast lesions.~PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of biopsy in patients who have breast lesions ... |
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, and safety of nitrocamptothecin when administered with etoposide in patients with advanced solid tumors. II. Determine the changes in expression and activity of topoisomerase I and II which occur during administration of this treatment regimen... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of nitrocamptothecin plus etoposide in treating patients who have advanced solid tumors. |
OBJECTIVES:~Determine the recommended phase II dose based on the maximum tolerated dose of BMS-188797 when administered with carboplatin in patients with advanced nonhematologic malignancies.~Assess the dose limiting toxicities and safety of this treatment regimen in these patients.~Determine the plasma pharmacokinetic... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.~PURPOSE: Phase I trial to study the effectiveness of BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer. |
OBJECTIVES: I. Determine the safety, tolerability, and toxicity of 3-AP in patients with advanced malignancies. II. Determine the maximum tolerated dose and recommended phase II dose of this treatment in these patients. III. Determine the pharmacokinetic parameters of this treatment in these patients. IV. Determine the... | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.~PURPOSE: Phase I trial to study the effectiveness of 3-AP in treating patients who have advanced cancer. |
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