Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
This trial is active, not recruiting.
|Treatments||bleomycin sulfate, filgrastim, stanford v regimen, doxorubicin hydrochloride, epirubicin hydrochloride, etoposide, mechlorethamine hydrochloride, prednisone, vinblastine sulfate, vincristine sulfate|
|Sponsor||Centro di Riferimento Oncologico - Aviano|
|Start date||May 1997|
|Trial size||30 participants|
|Trial identifier||NCT00003262, CDR0000066154, EU-97022, ITA-GICAT-POS5|
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.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically proven Hodgkin's disease: - Clinical or pathologic stage II - IV - Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms - Confirmed HIV infection PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-4 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No severe cardiac disease Pulmonary: - No severe pulmonary disease Other: - No severe neurologic or metabolic disease - No concurrent or prior second malignancy except: - Nonmelanomatous skin cancer - In situ cancer of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No prior therapy for Hodgkin's disease - Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
|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|
|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.|
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