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

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the objective response rate, response duration, and survival of patients with AIDS-related non-Hodgkin's lymphoma treated with lomustine, etoposide, cyclophosphamide, and procarbazine. Determine the feasibility of this regimen in these patients. Determine the clinical toxicity of this regimen in these patients. Assess the quality of life of patients treated with this regimen. Determine the impact of this regimen on the underlying HIV infection in these patients. OUTLINE: This is a multicenter study. Patients receive oral lomustine on day 1 (course 1 only), oral etoposide on days 1-3, and oral cyclophosphamide and oral procarbazine on days 22-26. Patients may also receive filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on days 1 and 22 of each course, at day 84, and then every 3 months for 1 year. Patients are followed at day 84 and then every 3 months. PROJECTED ACCRUAL: A total of 66 patients (22 in the United States and 44 in Africa) will be accrued for this study within 3-4 years.

Official Title
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Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa

Conditions
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Lymphoma

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of acquired immune deficiency syndrome Histologically confirmed stage I, II, III, or IV intermediate- or high-grade non-Hodgkin's lymphoma B-cell, T-cell, or indeterminate immunologic phenotype Measurable or evaluable disease No clinical, radiographic, or cytological evidence of CNS parenchymal, vitreal, or leptomeningeal involvement by lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of indolent or aggressive lymphoma will replace the former terminology of low, intermediate, or high grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age 18 and over (in the United States) 16 and over (in Africa) 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 Concurrent active infection for which patient is receiving treatment allowed provided clinical status is stable Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for lymphoma Endocrine therapy Not specified Radiotherapy Prior radiotherapy for stage I or II disease allowed provided there is documentation of disease progression Surgery Not specified Other Concurrent antiretroviral therapy (except zidovudine) allowed

Ages Eligible for Study
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Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.|
|Drug: cyclophosphamide|Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.|
|Drug: etoposide|Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.|
|Drug: lomustine|Oral lomustine on day 1 (course 1 only). Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.|
|Drug: procarbazine hydrochloride|Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease response |  | Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory |  | days 1 and 2 of courses 1 and 2 and on day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-related diffuse large cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related lymphoblastic lymphoma, AIDS-related small noncleaved cell lymphoma