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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bleomycin sulfate|nan|
|Biological: filgrastim|nan|
|Drug: Stanford V regimen|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: epirubicin hydrochloride|nan|
|Drug: etoposide|nan|
|Drug: mechlorethamine hydrochloride|nan|
|Drug: prednisone|nan|
|Drug: vinblastine sulfate|nan|
|Drug: vincristine sulfate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma