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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development Emory University |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004688 |
Purpose
OBJECTIVES:
I. Assess the clinical response of patients with refractory or recurrent brain neoplasms treated with carmustine, streptozocin, and mercaptopurine.
| Condition | Intervention | Phase |
|
Anaplastic Astrocytoma Anaplastic Oligodendroglioma Mixed Gliomas Glioblastoma Multiforme Recurrent Brain Tumor |
Drug: carmustine Drug: mercaptopurine Drug: streptozocin |
Phase II |
| MedlinePlus related topics: | Brain Cancer Cancer Childhood Brain Tumors |
| Drug Information available for: | Carmustine Mercaptopurine 6-Mercaptopurine Streptozocin |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 35 |
| Study Start Date: | August 1996 |
PROTOCOL OUTLINE:
Patients receive mercaptopurine IV on days 1-3, carmustine by continuous infusion on days 3-5, and streptozocin IV over 20 minutes on days 2-5. Patients receive treatment every 42 days, for up to 4 courses.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically proven refractory or recurrent brain neoplasms Glioblastoma multiforme Anaplastic astrocytoma Gliosarcoma Anaplastic oligodendroglioma Mixed anaplastic glioma Unequivocally progressive primary brainstem tumors following primary therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas or mitomycin Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed --Patient Characteristics-- Age: Not specified Performance status: ECOG 0-2 Karnofsky 60-100% Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times normal Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: FEV1 greater than 1 L if symptomatic pulmonary disease present Other: No other concurrent malignancies Not pregnant or lactating Negative pregnancy test Fertile patients must use effective contraception
Contacts and Locations| FDA Office of Orphan Products Development |
| Emory University |
| Study Chair: | Mark R. Gilbert | Emory University |
More Information
| Study ID Numbers: | 199/13310, EUSM-FDR001274 |
| First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004688 |
| Health Authority: | United States: Federal Government |
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