Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection

Lymphoma Clinical Trial

Official title: Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: "Stanford V Regimen" For "Low Risk" Patients, "EBVP Regimen" For "High Risk" Patients

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Hodgkin Disease
• Lymphoma

• NCT number: NCT00003262
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 1997