Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 54
- Locations
- 4
- Primary Endpoint
- Disease response
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over (in the United States)
- •16 and over (in Africa)
- •Performance status
- •Life expectancy
- •At least 6 weeks
- •Hematopoietic
- •WBC at least 1,500/mm3
- •Platelet count at least 50,000/mm3
- •Bilirubin no greater than 3.0 mg/dL
- •Creatinine no greater than 3.0 mg/dL
- •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
- •Not specified
- •Concurrent antiretroviral therapy (except zidovudine) allowed
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Disease response
Time Frame: Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Secondary Outcomes
- 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)