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Phase I Study of SU101 Administered by Four Weekly 24-Hour Infusions for Recurrent Malignant Gliomas (Summary Last Modified 07/97)
Alternate Title SU101 in Treating Patients with Recurrent Malignant Glioma
Objectives I. Assess the maximum tolerated dose of SU101 when given as a series of four weekly 24-hour infusions in patients with recurrent malignant glioma. II. Assess the pharmacokinetic/pharmacodynamic profile of this schedule of SU101 in these patients. Entry Criteria Disease Characteristics: Radiologically and/or pathologically confirmed malignant glioma of any of the following histologies: Anaplastic astrocytoma Anaplastic ependymoma Glioblastoma multiforme Anaplastic oligodendroglioma Anaplastic oligoastrocytoma Recurrent disease with no accepted alternative therapy No CNS lymphoma or CNS metastases secondary to unknown primary Prior/Concurrent Therapy: More than 4 weeks since any other investigational agent Biologic therapy: At least 4 weeks since immunotherapy Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: Not specified Patient Characteristics: Age: 18 and over Performance status: Karnofsky 50%-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000 ANC at least 1,500 Platelets at least 100,000 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin less than 1.5 times normal AST/ALT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: No allergy to etoposide No other medical or psychiatric contraindication to protocol therapy No history of second malignancy except: Basal cell skin carcinoma In situ carcinoma of the cervix No pregnant or nursing women Negative serum pregnancy test required of fertile women Effective contraception required of fertile patients Mini-mental status exam within 24 hours prior to treatment Blood/body fluid analyses within 7 days prior to treatment Imaging/exams for tumor measurement within 28 days prior to registration (within 14 days if disease rapidly progressive) Expected Enrollment Up to 45 patients will be treated. Outline Single-Agent Chemotherapy. SU101. Trial Lead Organizations Memorial Sloan-Kettering Cancer Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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