Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004072 |
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 combining O6-benzylguanine with carmustine in treating patients who have previously untreated, refractory, or relapsing multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: O6-benzylguanine Drug: carmustine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma |
Study Start Date: | September 1999 |
OBJECTIVES:
OUTLINE: Patients receive O6-benzylguanine IV over 60 minutes followed 1 hour later by carmustine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response (partial or complete response or stable or plateau disease).
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed progressive multiple myeloma, meeting 1 of the following criteria:
Major criteria:
Monoclonal globulin spike on serum electrophoresis
Minor criteria:
Must meet one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Evanston Northwestern Health Care - Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Lutheran General Cancer Care Center | |
Park Ridge, Illinois, United States, 60068 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
University of Illinois Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology, Incorporated | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Michigan | |
Oncology Care Associates, P.L.L.C. | |
Saint Joseph, Michigan, United States, 49085 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Stanton L. Gerson, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067280, CWRU-1A96, NCI-T97-0021 |
Study First Received: | December 10, 1999 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00004072 |
Health Authority: | United States: Federal Government |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Carmustine Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma O(6)-benzylguanine Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Cardiovascular Diseases Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |