drugset / Trial / NCT00360828
Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas
NaSingle-groupOpen-labelDiagnostic
Summary
Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
Timeline
- Start
- 2006-02
- Primary completion
- 2010-10
- Completion
- 2010-10
Outcome
Outcome not reported
Stopped (Enrollment): “Principal Investigator left Moffitt and study had low accrual.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 350 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 600 mg/m2 | Intravenous |