Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
|ClinicalTrials.gov Identifier: NCT00003262|
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 23, 2003
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||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||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
|Study Start Date :||May 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003262
|Centro di Riferimento Oncologico - Aviano|
|Aviano, Italy, 33081|
|Study Chair:||Umberto Tirelli, MD||Centro di Riferimento Oncologico - Aviano|