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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA062502 | U.S. NIH Grant/Contract | View source | |
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CWRU-1A96 | Other Identifier | Case Comprehensive Cancer Center | |
| NCI-T97-0021 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| O6-benzylguanine | Drug | Patients receive O6-benzylguanine 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. | ||
| carmustine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma. | Every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response. Patients are followed every 2 months. |
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DISEASE CHARACTERISTICS:
Histologically confirmed progressive multiple myeloma, meeting 1 of the following criteria:
Major criteria:
Plasmacytomas on tissue biopsy
Bone marrow plasmacytosis with greater than 30% plasma cells
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:
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| Name | Affiliation | Role |
|---|---|---|
| Stanton L. Gerson, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States | ||
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C064976 | O(6)-benzylguanine |
| D002330 | Carmustine |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Cleveland |
| Ohio |
| 44106-5065 |
| United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009603 |
| Nitroso Compounds |