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| Sponsor: | FDA Office of Orphan Products Development |
|---|---|
| Collaborator: |
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 |
| 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 More Information
| Study ID Numbers: | 199/13310, EUSM-FDR001274 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004688 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult brain stem glioma adult brain tumor adult glioblastoma multiforme adult infiltrating astrocytoma brain tumor |
genetic condition miscellaneous sites/terms mixed gliomas nervous tissue tumors oncologic disorders rare disease recurrent adult brain tumor |
|
Antimetabolites Glioblastoma Disease Attributes Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms 6-Mercaptopurine Antibiotics, Antineoplastic Brain Diseases Neoplasms by Site Pathologic Processes |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Alkylating Agents Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Carmustine Central Nervous System Diseases Enzyme Inhibitors Streptozocin Immunosuppressive Agents Pharmacologic Actions |
