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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-000224-01-1R4 | |||
| DUMC-000224-00-2R3 | |||
| DUMC-0348-99-2R2 | |||
| DUMC-223-97-2 | |||
| DUMC-229-98-2R1 | |||
| SB-DUMC-229-98-2R1 | |||
| NCI-G97-1242 | |||
| CDR0000065521 | Other Identifier | NCI |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.
OBJECTIVES:
OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week.
Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional
3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients.
Patients are evaluated after every 6 week cycle.
PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carmustine | Drug | |||
| topotecan hydrochloride | Drug |
DISEASE CHARACTERISTICS:
Histologically proven recurrent primary malignant glioma
PATIENT CHARACTERISTICS:
Age:
Performance Status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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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 | ||
| Saint Jude Children's Research Hospital |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002330 | Carmustine |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Memphis |
| Tennessee |
| 38105-2794 |
| United States |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009603 |
| Nitroso Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |