View Clinical Trial (Medical Research Study)

Combination Chemotherapy and Rituximab in Treating Patients With Previously Untreated AIDS-Related Non-Hodgkin's Lymphoma - NCT00020384-20892B(Clinical Trial 113526)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Bethesda
State:  
MD
Zip Code: 20892
Conditions: Lymphoma
Purpose: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and rituximab in treating patients who have previously untreated AIDS-related non-Hodgkin's lymphoma.
Study summary: OBJECTIVES: - Determine progression-free survival at 1 year in patients with previously untreated AIDS-related non-Hodgkin's lymphoma treated with a minimum of 3 courses of etoposide, vincristine, cyclophosphamide, doxorubicin, and rituximab. - Determine the toxicity of this regimen in these patients. - Determine the response rate and duration of response in these patients treated with this regimen. - Determine the effects of this regimen on CD4 cell depletion and recovery in these patients. - Assess the response of this patient population to antiretroviral therapy. OUTLINE: Patients receive etoposide IV, doxorubicin IV, and vincristine IV continuously on days 1-4, and cyclophosphamide IV over 30 minutes on day 5. Patients also receive rituximab IV immediately prior to chemotherapy on days 1 and 5. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive 1 additional course. After completion of study treatment, patients are followed at 2 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 28 months.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed aggressive CD20-positive diffuse large b-cell lymphoma - Any stage (I-IV) disease - Positive HIV serology required - No primary CNS lymphoma PATIENT CHARACTERISTICS: Age - 9 and over Performance status - ECOG 0-4 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 (unless impairment due to idiopathic thrombocytopenic purpura) Hepatic - Bilirubin less than 2.0 mg/dL OR - Total bilirubin no greater than 4.5 mg/dL (direct fraction no greater than 0.3 mg/dL if impairment due to protease inhibitor therapy) - AST and ALT no greater than 3 times upper limit of normal (ULN) (6 times ULN if impairment due to hyperalimentation) Renal - Creatinine no greater than1.5 mg/dL OR - Creatine clearance no greater than 50 mL/min - Creatinine according to age as follows (pediatric patients only): - 0.8 mg/dL (5 years and under) - 1.0 mg/dL (6 to 10 years) - 1.2 mg/dL (11 to 15 years) - 1.5 mg/dL (15 years and over) OR - Creatinine clearance greater than 60 mL/min (pediatric patients only) Cardiovascular - No current clinical heart failure or symptomatic ischemic heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other serious underlying medical condition that would preclude study participation - No infection other than HIV that would preclude study participation - No active inadequately treated opportunistic infection of the CNS - No severe AIDS-related wasting - No severe intractable diarrhea PRIOR CONCURRENT THERAPY: Biologic therapy - No prior rituximab Chemotherapy - No prior cytotoxic chemotherapy for NHL Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No concurrent antiretroviral therapy
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: July 2, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.