Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Treatments

Drug: cyclophosphamide

Drug: lomustine

Drug: procarbazine hydrochloride

Drug: etoposide

Biological: filgrastim

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00049439

CWRU-2498

NCI-G02-2126

P30CA043703 (U.S. NIH Grant/Contract)

CWRU-029828J

CASE-2498

CWRU2498

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

54 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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