Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma. Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients. OUTLINE: This is a multicenter study. Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Official Title
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Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: bleomycin sulfate
* Biological: filgrastim
* Drug: cyclophosphamide
* Drug: etoposide
* Drug: mitoxantrone hydrochloride
* Drug: prednisolone
* Drug: vincristine sulfate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following: Prior diagnosis of acquired immune deficiency syndrome (AIDS) CD4 count < 100,000/mm3 ECOG performance status > 2 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic: Not specified Chemotherapy: Not specified Endocrine: Not specified Radiotherapy: Not specified Surgery: Not specified

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: cyclophosphamide|nan|
|Drug: etoposide|nan|
|Drug: mitoxantrone hydrochloride|nan|
|Drug: prednisolone|nan|
|Drug: vincristine sulfate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Effects of treatment on response rate, time to disease progression, and survival |  |  | 

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