Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
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 II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients with AIDS-related lymphoma.
|Lymphoma||Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: methotrexate Drug: pegylated liposomal doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma|
|Study Start Date:||February 1999|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the one year survival and complete response rate of patients treated with doxorubicin HCl liposome/cyclophosphamide/vincristine/prednisone (Doxil-CVP) for AIDS-related lymphoma. II. Evaluate the toxicity of a combination chemotherapy regimen, Doxil-CVP, in this patient population. III. Evaluate the progression free and overall survival after treatment with Doxil-CVP in this patient population. IV. Evaluate the effects of treatment with Doxil-CVP on plasma viral mRNA levels, CD4+ lymphocyte count, and the incidences and types of opportunistic infections in this patient population.
OUTLINE: Patients are stratified according to disease characteristics. All patients receive a 30 minute infusion of doxorubicin HCl liposome IV, cyclophosphamide IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Filgrastim (G-CSF) is administered subcutaneously starting on day 6 and continues until the absolute neutrophil count is at least 10,000/mm3. Treatment courses are repeated every 21 days. Patients with lymphomatous bone marrow involvement and/or category J lymphoma receive cytarabine and methotrexate intrathecally weekly for 4 weeks. Patients with lymphomatous meningitis receive whole brain irradiation and an alternating intrathecal chemotherapy regimen. A minimum of 4 and a maximum of 8 courses are administered. Patients are removed from the study for progressive disease, stable disease after 4 courses, a life threatening infection that would delay treatment for more than 6 weeks, or any delay, except due to neutropenia, in chemotherapy treatment for more than 6 weeks. Patients who achieve a complete response receive an additional 2 courses of therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003388
|United States, California|
|Veterans Affairs Medical Center - Palo Alto|
|Palo Alto, California, United States, 94304|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|United States, New Jersey|
|Raritan Bay Medical Center|
|Perth Amboy, New Jersey, United States, 08861|
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|MBCCOP-Our Lady of Mercy Cancer Center|
|Bronx, New York, United States, 10466|
|Study Chair:||Matthew D. Volm, MD||New York University School of Medicine|