Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
16 Years
N/A
Both
Lymphoma
Trial Information
Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
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.
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:
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease response
Outcome Time Frame:
Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Safety Issue:
No
Principal Investigator
Scot C. Remick, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU2498
NCT ID:
NCT00049439
Start Date:
March 1998
Completion Date:
February 2008
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
