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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00049439
First received: November 12, 2002
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Drug: cyclophosphamide
Drug: etoposide
Drug: lomustine
Drug: procarbazine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Disease response [ Time Frame: Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: March 1998
Study Completion Date: February 2008
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    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.
    Drug: cyclophosphamide
    Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
    Drug: etoposide
    Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
    Drug: lomustine
    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.
    Drug: procarbazine hydrochloride
    Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049439

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Kenya
University of Nairobi College of Health Sciences
Nairobi, Kenya
Uganda
Uganda Cancer Institute
Kampala, Uganda
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Scot C. Remick, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Scot Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensvie Cancer Center
ClinicalTrials.gov Identifier: NCT00049439     History of Changes
Other Study ID Numbers: CWRU2498, P30CA043703, CWRU-029828J, CWRU-2498, NCI-G02-2126, CASE-2498
Study First Received: November 12, 2002
Last Updated: June 9, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Lomustine
Etoposide phosphate
Etoposide
Procarbazine
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 21, 2014