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

Phase 2

• Conditions: Lymphoma

• Registration Number: NCT00003262
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

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.

Study Timeline

• Study Start: 1997-05
• Study First Submitted: 1999-11-01
• Status Verified: 2002-10
• Study First Submitted QC: 2003-04-22
• Study First Posted: 2003-04-23
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Centro di Riferimento Oncologico - Aviano; 🇮🇹 Aviano, Italy