Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	16 and over	NCI	CWRU-029828J CWRU-2498, NCI-G02-2126, NCT00049439, CASE-2498

Objectives

1. 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.
2. Determine the feasibility of this regimen in these patients.
3. Determine the clinical toxicity of this regimen in these patients.
4. Assess the quality of life of patients treated with this regimen.
5. Determine the impact of this regimen on the underlying HIV infection in these patients.

Entry 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.

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

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

Expected Enrollment

A total of 66 patients (22 in the United States and 44 in Africa) will be accrued for this study within 3-4 years.

Outcomes

Disease response after course 2 and then every 3 months
Survival every 3 months
Toxicity as assessed by physical exam and laboratory tests on days 1 and 22 of courses 1 and 2 and on day 84

Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory on days 1 and 2 of courses 1 and 2 and on day 84

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Scot Remick, MD, Protocol chair		Ph: 216-844-5412

Registry Information
Official Title		Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
Trial Start Date		1998-03-13
Registered in ClinicalTrials.gov		NCT00049439
Date Submitted to PDQ		2002-09-16
Information Last Verified		2006-02-07
NCI Grant/Contract Number		P30-CA43703

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