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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-0059-00-1 | |||
| DUMC-T98-0059 | |||
| NCI-T98-0059 | |||
| CDR0000067688 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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 carmustine and O6-benzylguanine in treating patients who have recurrent or progressive glioma.
OBJECTIVES: I. Determine the activity of carmustine and O6-benzylguanine in patients with recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma resistant to nitrosourea. II. Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12-18 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| O6-benzylguanine | Drug | |||
| carmustine | Drug |
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma Resistant to nitrosourea (defined as progressive or recurrent disease within 8 weeks of receiving nitrosourea) Measurable residual disease by MRI or CT scan
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL BUN no greater than 25 mg/dL Pulmonary: DLCO greater than 80% predicted Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosourea, procarbazine, or mitomycin and recovered No prior nitrosourea greater than 1,200 mg/m2 Endocrine therapy: Concurrent stable dose corticosteroids allowed if on for at least two weeks prior to study Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
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| Name | Affiliation | Role |
|---|---|---|
| Henry S. Friedman, MD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System 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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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009603 |
| Nitroso Compounds |