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
- 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.
Primary Purpose: Treatment
Umberto Tirelli, MD
Centro di Riferimento Oncologico - Aviano
United States: Federal Government