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.

Condition	Treatment or Intervention	Phase
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	Drug: cyclophosphamide  Drug: etoposide  Drug: filgrastim  Drug: lomustine  Drug: procarbazine  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Michigan
      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202-2608,  United States; Recruiting
New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Ohio
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting
Kenya
      University of Nairobi College of Health Sciences, Nairobi,  Kenya; Recruiting
Uganda
      Uganda Cancer Institute, Kampala,  Uganda; Recruiting

Study chairs or principal investigators

Scot C. Remick, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000258098; CWRU-029828J; CWRU-2498; NCI-G02-2126; NCT00049439
Record last reviewed:  November 2002
Last Updated:  December 6, 2004
Record first received:  November 12, 2002
ClinicalTrials.gov Identifier:  NCT00049439
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08