Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma - Article
Clinical Trial: Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
This study is currently recruiting patients.
|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 |
Procedure: biological response modifier therapy
Procedure: colony-stimulating factor therapy
Procedure: cytokine therapy
|Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Lomustine, Etoposide, Cyclophosphamide, and Procarbazine in Patients With AIDS-Related Non-Hodgkin's Lymphoma
- 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
- 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)
- ECOG 0-3
- At least 6 weeks
- 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
- No prior chemotherapy for lymphoma
- Not specified
- Prior radiotherapy for stage I or II disease allowed provided there is documentation of disease progression
- Not specified
- Concurrent antiretroviral therapy (except zidovudine) allowed
Location and Contact Information
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202-2608, United States; Recruiting
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, 44106-5065, United States; Recruiting
University of Nairobi College of Health Sciences, Nairobi, Kenya; Recruiting
Uganda Cancer Institute, Kampala, Uganda; Recruiting
Scot C. Remick, MD, Study Chair, Ireland Cancer Center
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
Cache Date: April 9, 2005