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15681. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma

vaccinations every 2 weeks until a response is detected. Patients undergo peripheral blood mononuclear cell collection on week 14 followed by monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive one additional course of immunotherapy as above. Patients are followed at 1 week, monthly for 3 (...) astrocytoma Additional relevant MeSH terms: Layout table for MeSH terms Astrocytoma Nervous System Neoplasms Central Nervous System Neoplasms Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Aldesleukin Sargramostim Muromonab-CD3 Antineoplastic Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents

1999 Clinical Trials

15682. Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Melanoma

of interleukin-2 IV every other day over 10 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive one additional course of immunotherapy as above. Patients are followed every 3 months for 2 years, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official Title (...) : September 13, 2004 Last Update Posted: April 5, 2013 Last Verified: April 2013 Keywords provided by Barbara Ann Karmanos Cancer Institute: stage III melanoma stage IV melanoma recurrent melanoma Additional relevant MeSH terms: Layout table for MeSH terms Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Aldesleukin Muromonab-CD3 Antineoplastic Agents Anti-HIV Agents Anti-Retroviral

1999 Clinical Trials

15683. Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer That Has Been Removed With Surgery

on 3 consecutive days weekly for 6 weeks, followed by 2 weeks of rest. Patients receive 2 treatment courses, each 8 weeks in duration. Patients are followed every 6 months until death. PROJECTED ACCRUAL: A total of 20 patients will be accrued within 1 to 2 years. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 20 participants Primary Purpose: Treatment Official Title: A Multi-Center Adjuvant Trial of Outpatient Moderate-Dose (...) Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Interleukin-2 Aldesleukin Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

1999 Clinical Trials

15684. Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

dexamethasone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. Arm II: Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently (...) 1.5 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine less than 3.4 mg/dL Cardiovascular: No clinically significant cardiac insufficiency No uncontrolled hypertension Other: No uncontrolled diabetes mellitus No recent history of peptic ulceration HIV-1 and HIV-2 negative Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic peripheral blood stem cell

1999 Clinical Trials

15685. Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission. Compare the toxicity of these 2 regimens in these patients. Assess the quality of life of these patients. OUTLINE: This is a randomized study. Patients are stratified according to number of courses of induction therapy required to achieve complete remission. All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7. Patients (...) receive 1-2 courses of induction chemotherapy to achieve complete remission. Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission. Arm I: Patients receive 2 courses of mitoxantrone IV on days 1 and 2, etoposide IV over 1 hour on days 1-5, and cytarabine IV over 12 hours on days 1-5. Arm II: Patients receive 2 courses of oral idarubicin and etoposide on days 1-3. Quality of life is assessed before each course of consolidation chemotherapy

1999 Clinical Trials

15686. Biological Therapy Plus Chemotherapy in Treating Patients With Metastatic or Recurrent Kidney Cancer

node metastases only vs other disease site), radiotherapy (yes vs no), and prior adjuvant biologic or hormone therapy (yes vs no). Patients receive intravenous fluorouracil daily for 14 days, and subcutaneous interferon alfa-2b 3 times a week for 6 weeks. Beginning on day 15, patients receive intravenous interleukin-2, 5 days a week and oral isotretinoin 2 times a day for 4 weeks. Treatment courses are 6 weeks, followed by a 2 week rest period. Treatment continues for up to 4 courses in the absence (...) antibiotics Not HIV positive No active substance abuse PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior interleukin-2 therapy At least 6 months since prior interferon alfa therapy At least 1 month since other prior biologic therapy No other concurrent biologic therapy (e.g., filgrastim or sargramostim) Chemotherapy: At least 6 months since prior fluorouracil therapy At least 1 month since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 1 month since

1999 Clinical Trials

15687. Combination Chemotherapy With or Without Prednisone in Treating Patients With Recurrent and/or Metastatic Kidney Cancer

prednisone is given to patients with an elevated erythrocyte sedimentation rate. A course of treatment consists of 6 weeks of treatment followed by 2 weeks of rest. Patients with stable disease may receive up to 4 courses of treatment. Patients who achieve a partial response may undergo surgical resection followed by up to 2 additional courses of treatment or an interleukin-2 treatment regimen. Patients with a complete response receive 1 additional course of treatment. Patients are followed until death (...) status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious illness No serious active infection requiring therapy HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior vinca alkaloid No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy No concurrent

1999 Clinical Trials

15688. Docetaxel in Treating Patients With Solid Tumors

. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 109 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients Study Start Date (...) : September 1998 Actual Primary Completion Date : January 2006 Actual Study Completion Date : January 2008 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: docetaxel OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician. Drug: docetaxel Outcome Measures Go

1999 Clinical Trials

15689. Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

to high-dose IL-2 on the toxicity of the treatment in these patients. Define the induction of T-cell responses to gp100:209-217 (210M) peptide and its gp100 (parent) protein by ELISA with interferon gamma production or CTL precursor frequencies in these patients after the initial course of treatment. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (adjuvant interferon vs chemotherapy for advanced disease vs both vs none), ECOG performance status (0 (...) IL-2 beginning on day 2 of each treatment week (4, 7, and 10) for up to 14 doses. Patients in each arm may receive up to a total of 3 courses of treatment. Patients are followed until death. PROJECTED ACCRUAL: Approximately 90 patients (25 patients for arms I and II and 40 patients for arm III [arm III closed to accrual as of 11/30/1998]) will be accrued for this study within 12-18 months. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial

1999 Clinical Trials

15690. Gene Therapy and Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

over 1 hour every 6 weeks for 5 courses, assuming recovery of peripheral blood counts. Approximately 72 hours after the end of the first course of chemotherapy, patients receive reinfusion of retrovirally-transduced hematopoietic stem cells over 5-10 minutes. Four weeks after the completion of BG and carmustine, patients receive BG IV over 1 hour followed by temozolomide IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may (...) continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity provided other phase II studies indicate the safety of more than 5 courses. Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine. Patients are followed monthly for 2 months, every 4 months for 8 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study

1999 Clinical Trials

15691. Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer

or high dose adjuvant chemotherapy. Arm I: Patients receive conventional chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil IV administered once every 3 weeks for 8 courses. Arm II: Patients receive high dose chemotherapy. Cyclophosphamide IV is administered on day 1. Patients undergo peripheral blood progenitor cell (PBPC) collection, then receive cyclophosphamide and thiotepa IV for 4 days, 13-28 days after PBPC collection. Peripheral blood progenitor cells (...) information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 60 Years (Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically proven locally advanced, inflammatory, or operable large primary breast cancer (greater than 3 cm) following 2-6 courses of primary anthracycline-containing chemotherapy Potentially curative surgery At least 1 axillary lymph node involvement at surgery No metastatic disease Hormone

1999 Clinical Trials

15692. Combination Chemotherapy in Treating Women With Breast Cancer

. Patients receive a maximum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Patients then undergo surgery (if operable) followed by more chemotherapy (if node positive), radiation therapy, and oral tamoxifen for 5 years (at the discretion of the investigator for estrogen receptor-negative patients). Patients are followed at 12, 18, and 24 months, and then annually for at least 5 years. PROJECTED ACCRUAL: A total of 350 patients (175 per arm) will be accrued (...) ) Renal: Creatinine normal Cardiovascular: Adequate cardiac function No active cardiac disease Other: Not pregnant Fertile patients must use effective contraception No other serious medical or psychiatric disease No prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease

1999 Clinical Trials

15693. CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse

Detailed Description: OBJECTIVES: I. Assess the efficacy of CMA-676 in elderly patients with acute myeloid leukemia in first relapse in terms of the number of patients attaining a complete remission. II. Assess the safety of CMA-676 in this patient population. OUTLINE: This is an open label, single arm, multicenter study. Patients receive 1 course of CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period. Patients may receive 1 additional course of therapy 15 to 28 days later (...) Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: No uncontrolled cardiac disease Pulmonary: No uncontrolled pulmonary disease Other: No other active malignancy No uncontrolled, life-threatening infections Able to obtain bone marrow aspirate HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow and peripheral blood stem cells transplantation No prior anti-CD33 antibody therapy Chemotherapy: Prior cytotoxic chemotherapy for AML allowed No prior chemotherapy for AML

1999 Clinical Trials

15694. Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer

treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients. OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease (...) limit of normal (ULN) Renal: Creatinine no greater than ULN Cardiovascular: No active cardiac disease No unstable angina No myocardial infarction within 6 months No congestive heart failure No inability to tolerate hypotension Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No uncontrolled diabetes mellitus No psychiatric disorders No concurrent secondary malignancies except nonmelanomatous skin cancer or patients with less than a 30% risk of relapse

1999 Clinical Trials

15695. Combination Chemotherapy and Biological Therapy In Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed Surgically

. OUTLINE: Patients receive fluorouracil IV on days 1, 8, 15, and 22, followed by gemcitabine IV over 30 minutes on days 29, 36, 43, and 50. Interferon alfa is administered subcutaneously 3 times weekly beginning on day 1. Beginning on day 2, interleukin-2 is administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course. Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic effects and disease progression. Following chemobiotherapy (...) than 2.0 mg/dL Calcium less than 12 mg/dL Proteinuria no greater than 2.0 by dipstick Cardiovascular: No active angina No uncontrolled congestive heart failure No uncontrolled arrhythmias No myocardial infarction within 6 months Pulmonary: No significant pulmonary disease (RA pO2 less than 60 or pCO2 greater than 50) Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection No daily emesis or inability to tolerate solid foods No prior

1999 Clinical Trials

15696. Rituximab and Dexamethasone in Treating Patients With Recurrent or Refractory Indolent Non-Hodgkin's Lymphoma

dexamethasone, and patients who did not receive maintenance rituximab. OUTLINE: Patients receive dexamethasone IV followed by rituximab IV on days 1, 8, 15, and 22 for one course. Two months after initiating treatment, patients are evaluated for disease progression. Patients with stable or responding disease may receive monthly dexamethasone and rituximab therapy for up to 10 additional months. Patients are followed every 3 months for 2 years, then every 6 months for years 3-4, and then yearly for up to 5 (...) or visceral lesion at least 2 cm in diameter PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection HIV negative No hepatitis B or C No concurrent life threatening condition PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy

1999 Clinical Trials

15697. Gene Therapy in Treating Patients With Non-Small Cell Lung Cancer That Cannot Be Surgically Removed

Intervention/treatment Phase Lung Cancer Biological: Ad5CMV-p53 gene Phase 1 Detailed Description: OBJECTIVES: Evaluate the safety of multiple endobronchial treatments with adenovirus p53 bronchoalveolar lavage of a single lobe of the lung in patients with bronchoalveolar cell lung carcinoma. Evaluate expression of the p53 gene and induction of apoptosis in tumor and normal tissues exposed to the virus in these patients. Evaluate whether transbronchial administration of adenovirus p53 results in improved (...) local tumor control in these patients. OUTLINE: This is a dose escalation study. Patients undergo biopsy and receive adenovirus p53 by bronchoalveolar lavage on days 1 and 15. Patients repeat biopsy on days 3 and 28. If there is evidence of clinical benefit or response without significant toxicity, patients may receive a maximum of 3 courses. Treatment beyond 3 courses must be approved by protocol investigator. Cohorts of 3 patients are treated at escalating dose levels of adenovirus p53. Patients

1999 Clinical Trials

15698. Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10. Patients with stable or responding disease may receive additional courses every 28 days. Patients are followed every 4 months. PROJECTED ACCRUAL: A total of 280 patients (140 in each arm) will be accrued for this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official (...) 2.0 mg/dL Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders Contacts

1999 Clinical Trials

15699. Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

is performed. Patients with stable or responding disease may receive additional courses of 6 injections. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 78 participants Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma Study Start Date (...) 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal; PT/PTT normal LDH and albumin normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease Other: HIV negative; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus

1999 Clinical Trials

15700. Temozolomide in Treating Patients With Progressive Low-Grade Glioma

in patients with progressive low-grade gliomas treated with temozolomide. Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients. OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma). Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression (...) or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 100 participants Primary Purpose: Treatment Official Title: Phase II Treatment of Adults and Children

1999 Clinical Trials

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