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

Sponsor

Centro di Riferimento Oncologico - Aviano (Other)

Overall Status

Unknown status

CT.gov ID

NCT00003262

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: bleomycin sulfate Biological: filgrastim Drug: Stanford V regimen Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 1997