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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
filgrastim
cyclophosphamide
etoposide
lomustine
procarbazine hydrochloride
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • University of Nairobi College of Health Sciences
  • Uganda Cancer Institute

Outcomes

Primary Outcome Measures

Disease response

Secondary Outcome Measures

Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory

Full Information

First Posted
November 12, 2002
Last Updated
June 9, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00049439
Brief Title
Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
Official Title
Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
lomustine
Intervention Description
Oral lomustine on day 1 (course 1 only). Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
procarbazine hydrochloride
Intervention Description
Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Disease response
Time Frame
Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Secondary Outcome Measure Information:
Title
Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory
Time Frame
days 1 and 2 of courses 1 and 2 and on day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scot C. Remick, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
University of Nairobi College of Health Sciences
City
Nairobi
Country
Kenya
Facility Name
Uganda Cancer Institute
City
Kampala
Country
Uganda

12. IPD Sharing Statement

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

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