NCT00003262

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centro di Riferimento Oncologico - Aviano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 1997-05-01
• First posted: 2003-04-23
• Last updated: 2013-09-20

Locations

1 site across 1 country: Italy