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Clinical Trials/NCT00003262
NCT00003262UnknownPhase 2

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

Centro di Riferimento Oncologico - Aviano2 sites in 1 country30 target enrollmentStarted: May 1997Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
30
Locations
2

Study Overview

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:

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Study Sites (2)

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