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Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: November 12, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Ireland Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049439
  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 II

Study Type: Interventional
Study Design: Treatment, Open Label
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease response after course 2 and then every 3 months [ Designated as safety issue: No ]
  • Survival every 3 months [ Designated as safety issue: No ]
  • Toxicity as assessed by physical exam and laboratory tests on days 1 and 22 of courses 1 and 2 and on day 84 [ Designated as safety issue: Yes ]

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

Study Start Date: March 1998
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049439

Locations
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202-2608
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 of Cleveland and Case Western Reserve University
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
Ireland Cancer Center
Investigators
Study Chair: Scot C. Remick, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000258098, CWRU-029828J, CWRU-2498, NCI-G02-2126, CASE-2498
Study First Received: November 12, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00049439     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Lomustine
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Procarbazine
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Alkylating Agents
Lymphoma
Etoposide

ClinicalTrials.gov processed this record on November 27, 2009