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

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Case Comprehensive Cancer Center
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:	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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclophosphamide Lomustine Etoposide Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor Procarbazine hydrochloride Procarbazine

U.S. FDA Resources

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:

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.

Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

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.

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Scot C. Remick, MD

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012