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HIV Course

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15781. S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

. Determine the toxicity of this treatment in these patients. OUTLINE: Patients receive rituximab IV on days 1 and 8 of the first course, then on day 1 of courses 2 and 3. Patients receive cyclophosphamide IV over 1-2 hours, doxorubicin IV, and vincristine IV on day 10 of the first course, then on day 3 of courses 2 and 3. Patients receive oral prednisone on days 10-14 of the first course, then on days 3-7 of courses 2 and 3. Treatment repeats every 21 days for 3 courses in the absence of disease (...) Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No medical contraindications to CHOP chemotherapy or rituximab No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No AIDS or HIV Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody

2000 Clinical Trials

15782. S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease

or nursing Fertile patients must use effective contraception No HIV or AIDS No other prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer No active bacterial, fungal, or viral infection* Afebrile for 3 consecutive days* NOTE: *Prior to randomization portion of study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease except single course of ABVD (doxorubicin, bleomycin, vinblastine (...) , and dacarbazine IV over 15-30 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms. Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8 courses. Arm II: Patients receive 1 additional course of induction chemotherapy followed

2000 Clinical Trials

15783. Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 37 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients (...) With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993) Study Start Date : February 2000 Actual Primary Completion Date : June 2002 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Arm I Patients receive rebeccamycin analogue IV once on day 1. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months

2000 Clinical Trials

15784. 506U78 in Treating Patients With Lymphoma

with an increased risk of HIV infection should be tested for exposure to the HIV virus; patients who test positive or who are known to be infected are not eligible; an HIV test is not required for entry on protocol, but is required if the patient is perceived to be at risk Calculated Creatinine Clearance >= 50 ml/min Unless attributable to lymphoma To be calculated by method of Cockcroft-Gault Bilirubin >= 1.5 x upper limit of normal Patients with hepatic dysfunction should enroll on CALGB 69803 Contacts (...) the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78. II. Determine the safety and toxicity of this treatment regimen in this patient population. OUTLINE: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response

2000 Clinical Trials

15785. Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction

first course of study Chemotherapy: No more than 3 prior regimens of chemotherapy At least 6 weeks since prior platinum chemotherapy At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 30% of bone marrow Surgery: At least 10 days since placement of biliary shunt Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in HIV positive patients Contacts and Locations Go to Information

2000 Clinical Trials

15786. Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer

, multicenter study. Patients receive Leuvectin intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14. Patients are re-evaluated at week 10. Treatment repeats every 10-11 weeks or 1-6 days after completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years in the absence of disease progression. ACTUAL ACCRUAL: A total (...) ; Symptoms of coronary artery disease; History of any ventricular arrhythmia; Prior myocardial infarction. Other: HIV negative. Fertile patients must use effective double-barrier contraception during and for 3 months after study participation. No active autoimmune disease. No active infection requiring IV antibiotics. No uncontrolled diabetes mellitus. No significant psychiatric disorder that would preclude study. No other malignancy within the past 5 years except adequately treated basal cell

2000 Clinical Trials

15787. Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors

in these patients. III. Assess the development of peripheral neuropathy in these patients on the Mayo regimen. IV. Determine the activity of these regimens in patients with metastatic solid tumors. OUTLINE: This is a dose escalation study. Patients are entered to one of two treatment arms: Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22, followed by oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 6 (...) weeks. Arm II (Mayo regimen): Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1, followed by leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks. Cohorts of 3-6 patients receive escalating doses of fluorouracil (one of two treatment doses for arm II), and one of two treatment doses of irinotecan and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding

2000 Clinical Trials

15788. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome

apoptosis in circulating blasts in this patient population. III. Assess the antileukemic effects of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive PS-341 IV bolus twice weekly for 4 weeks followed by 2 weeks of rest. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 2 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined (...) Actual Primary Completion Date : October 2002 Resource links provided by the National Library of Medicine related topics: related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Treatment (bortezomib) Patients receive PS-341 IV bolus twice weekly for 4 weeks followed by 2 weeks of rest. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Drug: bortezomib Given IV Other Names: LDP 341

2000 Clinical Trials

15789. Temozolomide in Treating Women With Advanced Breast Cancer

. Assess the therapeutic activity of temozolomide in terms of tumor response, progression free and overall survival in women with advanced breast cancer. II. Assess the extent of ATase depletion and DNA methylation in the peripheral blood of these patients undergoing this regimen and investigate the relationship between these parameters and tumor response. OUTLINE: Patients receive oral temozolomide every 4 hours for a total of 5 doses. Treatment continues every 28 days for a minimum of 2 courses (...) with study evaluations No uncontrolled vomiting that would preclude administration of oral medications HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Recovered from prior surgery Other: No other concurrent experimental drugs Contacts and Locations Go

2000 Clinical Trials

15790. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

of noncytotoxic maintenance therapy following high dose chemotherapy in this patient population. OUTLINE: This is a multicenter study. Patients with no prior chemotherapy for metastatic disease receive induction chemotherapy consisting of doxorubicin IV immediately followed by docetaxel IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) subcutaneously (SQ) beginning on day 2 and continuing until day 11-15. Induction therapy repeats every 3 weeks for 4 courses. Within 4 weeks of the last course (...) 3.0 mg/dL SGOT no greater than 6 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: Ejection fraction at least 40% by MUGA scan No angina pectoris requiring active nitrate therapy No myocardial infarction within the past 6 months No uncontrolled congestive heart failure No uncontrolled hypertension No major ventricular arrhythmia Other: No uncompensated endocrine dysfunction HIV negative Hepatitis B negative (core

2000 Clinical Trials

15791. Stem Cell Transplantation in Treating Patients With Hematologic Cancer

is available OR Histologically proven acute myeloid leukemia (AML) without an available HLA matched sibling donor and with one of the following: Failure of induction, defined as inability to obtain remission with 2 courses of induction or failure during treatment Second or greater remission OR Histologically proven acute lymphocytic leukemia (ALL) in an adult over age 15 without an available HLA matched sibling donor and with one of the following: Philadelphia chromosome positivity by cytogenetics or PCR (...) SGOT and SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No coronary artery disease requiring medical therapy Resting LVEF at least 40% Pulmonary: FEV1/FVC at least 60% predicted DLCO at least 60% predicted Other: HIV negative No prior malignancy except basal cell or squamous cell skin cancer Other malignancies for which the patient is cured by local surgical therapy, such as head

2000 Clinical Trials

15792. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

: melphalan Procedure: peripheral blood stem cell transplantation Phase 2 Detailed Description: OBJECTIVES: I. Determine the feasibility and activity of intensive therapy with 3 noncross resistant chemotherapeutic regimens (cyclophosphamide, etoposide, cisplatin, cytarabine, and tandem courses of high dose melphalan with stem cell rescue) in patients with chemotherapy sensitive multiple myeloma. II. Determine the incidence of hematologic and nonhematologic toxicities of this regimen in this patient (...) population. III. Determine the time to hematologic recovery after high dose melphalan in these patients. IV. Determine the response rate after each course of therapy in these patients. V. Determine the disease free, relapse free, and overall survival of these patients treated on this regimen. VI. Determine the incidence of toxicities attributable to interferon alfa and the ability to continue interferon alfa therapy as maintenance in these patients. OUTLINE: Patients are stratified according

2000 Clinical Trials

15793. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

or medical condition that would preclude administration of high dose therapy No other prior malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix No uncompensated endocrine dysfunction HIV negative Hepatitis B negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior course of adjuvant therapy No other prior chemotherapy for metastatic breast cancer At least 6 months since prior adjuvant therapy

2000 Clinical Trials

15794. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer

for administration in conjunction with protocol-directed chemotherapy No other concurrent uncontrolled illness No ongoing or active infection No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: No colony-stimulating factor therapy during first study course Chemotherapy: No prior chemotherapy for esophageal cancer At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for esophageal cancer At least 4 weeks since (...) other prior radiotherapy Surgery: No prior resection or attempted resection of esophageal cancer Other: No other concurrent investigational drugs No other concurrent commercial agents or therapies for esophageal cancer No concurrent highly active antiretroviral agents (HAART) for HIV-positive patients Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information

2000 Clinical Trials

15795. Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation

(Child, Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Diagnosis of one of the following: Acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) in first early relapse, second remission, or subsequent remission AML in first complete remission with one of the following adverse features: Antecedent hematologic disorder such as myelodysplasia AML resulting from prior chemotherapy or radiotherapy More than 1 course of induction (...) or SGPT less than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF greater than 50% without medication Pulmonary: DLCO and FVC at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious medical illness No uncontrolled diabetes mellitus No uncontrolled and/or active infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy and recovered

2000 Clinical Trials

15796. Pilot Study of Atorvastatin in Children With Chronic Hyperlipidemia Secondary to Nephrotic Syndrome

at a dose of no greater than 1 mg/kg every other day (maximum dose, no greater than 40 mg every other day); Concurrent acute courses of steroids no greater than 1 week for other unrelated conditions (e.g., asthma) also allowed --Patient Characteristics-- Hepatic: ALT or AST less than 2 times normal Renal: See Disease Characteristics; Creatine phosphokinase less than 3 times normal Other: No history of familial hypercholesterolemia; No systemic disease such as systemic lupus, Schoenlein-Henoch purpura (...) , Hodgkin's disease, polyarteritis nodosum, sickle cell disease, or HIV; Not pregnant; Effective contraception required of all adolescent patients Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004466 Locations Layout table for location information

1999 Clinical Trials

15797. Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis

for 3 days. Patients in arm III receive streptomycin intramuscularly once a day for 3 days. All patients then begin a course of standard therapy for tuberculosis. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 24 participants Allocation: Randomized Primary Purpose: Treatment Study Start Date : November 1994 Study Completion Date : January 2001 Resource links provided by the National Library of Medicine related topics: available (...) in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB Hospitalization, within 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred No clinical evidence of CNS or miliary tuberculosis HIV seronegative --Prior/Concurrent Therapy-- Biologic therapy: At least 12 weeks since immune modulators (including colony-stimulating factors, interferons, or interleukins) Chemotherapy: No concurrent chemotherapy Endocrine

1999 Clinical Trials

15798. International Registry for Severe Chronic Neutropenia

for Research Resources (NCRR) Collaborator: University of Washington Information provided by: National Center for Research Resources (NCRR) Study Details Study Description Go to Brief Summary: OBJECTIVES: I. Document the clinical course of severe chronic neutropenia (SCN). II. Monitor and assess long term safety of primary treatment in SCN patients in the United States, Canada, Europe, and Australia. III. Study the incidence and outcome of adverse events such as osteoporosis, splenomegaly, cytogenetic (...) suggested --Prior/Concurrent Therapy-- At least 5 years since prior chemotherapy --Patient Characteristics-- No rheumatoid arthritis No systemic lupus erythematosus No HIV seropositivity Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004342 Locations

1999 Clinical Trials

15799. A Randomized, Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir + Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive

Update Posted: June 24, 2005 Last Verified: April 1999 Keywords provided by NIH AIDS Clinical Trials Information Service: Drug Therapy, Combination HIV Protease Inhibitors RNA, Viral Reverse Transcriptase Inhibitors Viral Load Nelfinavir Uracil Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes (...) is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00002215 Recruitment Status : Completed First Posted : August 31, 2001 Last Update Posted : June 24, 2005 Sponsor: Triangle Pharmaceuticals Information provided by: NIH AIDS Clinical Trials Information Service Study Details Study Description Go to Brief Summary: To compare the proportion of patients whose plasma HIV

1999 Clinical Trials

15800. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

Immunodeficiency Syndrome Paclitaxel Treatment Outcome Antineoplastic Agents, Phytogenic Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections (...) . To evaluate the clinical benefit of paclitaxel in this patient population by evaluating self-reported responses to the Symptom Distress Scale and by documenting and evaluating any changes in their lymphedema, pain and disfiguring facial lesions. Condition or disease Intervention/treatment Phase Sarcoma, Kaposi HIV Infections Drug: Paclitaxel Phase 2 Detailed Description: Patients are treated with paclitaxel intravenously every 2 weeks up to 10 courses. Patients who achieve a complete response receive 2

1999 Clinical Trials

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