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| Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003114 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients with stage IIB, stage III, or stage IV AIDS-related Hodgkin's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Drug: cyclophosphamide Drug: etoposide Drug: lomustine Drug: procarbazine hydrochloride Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease |
| Estimated Enrollment: | 16 |
| Study Start Date: | July 1997 |
OBJECTIVES:
OUTLINE: Patients receive oral lomustine on day 1, oral etoposide on days 1-3, and oral cyclophosphamide and procarbazine on days 22-31. Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42. The course is repeated every 6 weeks.
Patients with a complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy. Patients failing to respond after 1 course are removed from the study.
Patients will be followed every 3 months until death.
PROJECTED ACCRUAL: A minimum of 16 evaluable patients will be accrued.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage IIB-IV AIDS-related Hodgkin's disease
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, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Scot C. Remick, MD | Case Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000065864, CWRU-2496, AMC-4A-90, NCI-G97-1351 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003114 History of Changes |
| Health Authority: | United States: Federal Government |
|
AIDS-related lymphoma HIV-associated Hodgkin lymphoma |
|
Lymphoma, AIDS-related Immunoproliferative Disorders Immunologic Factors Hodgkin Lymphoma, Adult Lomustine Acquired Immunodeficiency Syndrome Hodgkin's Disease Cyclophosphamide Immunosuppressive Agents Etoposide phosphate Lymphatic Diseases |
Lymphoma, AIDS-Related HIV Infections Primary Effusion Lymphoma Antineoplastic Agents, Alkylating Procarbazine Antirheumatic Agents Lymphoproliferative Disorders Alkylating Agents Etoposide Lymphoma Hodgkin Disease |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases |
Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Procarbazine Antirheumatic Agents Lymphoproliferative Disorders Alkylating Agents Hodgkin Disease Lymphoma |
