Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|