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| 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 |
| Study Start Date: | March 1998 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I, II, III, or IV intermediate- or high-grade non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and 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 | |
| Study Chair: | Scot C. Remick, MD | Case Comprehensive Cancer Center |
More Information
| 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 |
|
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 |
|
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 |