drugset / Trial / NCT00360828

Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

NCT00360828 ↗

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

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 350 mg/m2 Intravenous
Subject Irinotecan Small molecule 600 mg/m2 Intravenous