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Phase II Study of Aminocamptothecin in Malignant Gliomas (Summary Last Modified 10/97)
Basic Trial Information
Objectives I. Evaluate the activity of aminocamptothecin (9-AC) in refractory or progressive malignant gliomas. II. Characterize the toxicity of 9-AC and determine the duration of response, time to progression, and survival. III. Characterize the pharmacokinetics and pharmacodynamics of 9-AC in patients treated on this study and similar studies involving patients with other tumor types. Entry Criteria Disease Characteristics: Histologically or cytologically confirmed malignant glioma, including: Grade III/IV astrocytoma Anaplastic astrocytoma Grade IV ependymoma Recurrent oligodendroglioma Prior low-grade astrocytoma that has developed features of glioblastoma multiforme Progressive disease following surgery and radiotherapy required by one of the following: Histologic documentation Unequivocal evidence by CT or MRI Unequivocal clinical progression Steroid dose stable for at least 7 days prior to entry Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) No more than 1 prior chemotherapy regimen allowed, e.g.: Adjuvant chemotherapy Chemotherapy concomitantly with radiotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 2 weeks since major surgery Patient Characteristics: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,500 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dl (unless attributed to Gilbert's disease) SGOT no greater than 2 x normal Alkaline phosphatase no greater than 2 x normal Renal: Creatinine no greater than 1.5 mg/dl Other: No pregnant or nursing women Effective contraception required of fertile patients Expected Enrollment If at least 1 response is seen in the first 14 patients, an additional 26 patients will be enrolled. Accrual is expected to require 2 years. Outline Single-Agent Chemotherapy. Aminocamptothecin, 9-AC, NSC-603071. Trial Lead Organizations University of Chicago Cancer Research 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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