Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease

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 combination chemotherapy with lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients with stage IIB, stage III, or stage IV AIDS-related Hodgkin's disease.

Detailed Description
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OBJECTIVES: Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease. Assess the feasibility and toxic effects of CECP in this patient population. OUTLINE: Patients receive oral lomustine on day 1, oral etoposide on days 1-3, and oral cyclophosphamide and procarbazine on days 22-31. Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42. The course is repeated every 6 weeks. Patients with a complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy. Patients failing to respond after 1 course are removed from the study. Patients will be followed every 3 months until death. PROJECTED ACCRUAL: A minimum of 16 evaluable patients will be accrued.

Official Title
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Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: filgrastim
* Drug: cyclophosphamide
* Drug: etoposide
* Drug: lomustine
* Drug: procarbazine hydrochloride
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven stage IIB-IV AIDS-related Hodgkin's disease Patients with Hodgkin's disease as the only HIV-related condition must have a positive ELISA for HIV confirmed by Western Blot Measurable or evaluable disease No cytologic or radiologic evidence of CNS involvement PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-3 Life expectancy: At least 6 weeks Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Other: Active infection is allowed (provided prognosis is estimated to be at least 6 weeks) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease At least 4 weeks since chemotherapy for Kaposi's sarcoma Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for localized stage I or II disease that has progressed beyond initial radiation ports is allowed Surgery: Not specified Other: Concurrent AZT therapy is allowed
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42.The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.|
|Drug: cyclophosphamide|Oral cyclophosphamide on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.|
|Drug: etoposide|Oral etoposide on days 1-3. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.|
|Drug: lomustine|Patients receive oral lomustine on day 1.|
|Drug: procarbazine hydrochloride|Oral and procarbazine on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.|
|Radiation: radiation therapy|Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease. |  | The course is repeated every 6 weeks. Patients will be followed every 3 months until death. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-related lymphoma, HIV-associated Hodgkin lymphoma