Lymphoma
Conditions
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma
Brief summary
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 II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.
Detailed description
OBJECTIVES: * Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone. OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm\^3). * Low risk patients (those with no risk factors) receive the EBVP regimen, as follows: * Epirubicin intravenously on day 1 * Bleomycin intramuscularly or intravenously on day 1 * Vinblastine intravenously on day 1 * Prednisone orally on days 1-5 * Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses. * High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows: * Doxorubicin and vinblastine intravenously on days 1 and 15 * Mechlorethamine intravenously on day 1 * Vincristine and bleomycin intravenously on days 8 and 22 * Etoposide intravenously on days 15 and 16 * Prednisone orally daily * Patients also receive daily injections of G-CSF on days 3-7, 9-13, 17-21, and 23-26. This schedule is repeated every 28 days for 3 courses. Patients are followed every 2 months the first year and then every 3 months thereafter. PROJECTED ACCRUAL: 20-30 patients will initially be accrued in this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven Hodgkin's disease: * Clinical or pathologic stage II - IV * Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms * Confirmed HIV infection PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-4 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No severe cardiac disease Pulmonary: * No severe pulmonary disease Other: * No severe neurologic or metabolic disease * No concurrent or prior second malignancy except: * Nonmelanomatous skin cancer * In situ cancer of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for Hodgkin's disease * Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
Countries
Italy