Treatment > Irinotecan / Temozolomide Clinical Trials

Meeting Abstract

Phase II Treatment of Recurrent Malignant Astrocytoma with Temozolomide and Irinotecan

Michael L. Gruber, Deborah B Gruber

New York University Medical Center, Englewood, NJ

The prognosis for patients with recurrent malignant astrocytoma is poor. 
Both Temozolomide and Irinotecan have been shown to be active in this disease. 
We peformed a Phase II trial combining Temozolomide 200 mg/m2 daily for 5 days and Irinotecan 125 mg/m2 on days 6, 13, & 20 initially [Schedule A] and then changed to [Schedule B] Temozolomide 200 mg/m2 daily for 5 days and Irinotecan 350 mg/m2 on day 6. 
Each cycle was 28 days. 
Patients had to complete two cycles of therapy to be evaluable. 
Thirteen patients [11 GBM, 2 Anaplastic mixed AO] were treated on schedule A and nine patients [7 GBM, 2 Anaplastic mixed AO] were given Schedule B. 
The first patient was treated on 11/4/99. 
The protocol called for 6 cycles of treatment for responders [CR, PR, SD]. 
There were 4 responses seen in GBM patients on schedule A [2 PR, 2 SD] and 6 responses noted in GBM patients on Schedule B [2 PR, 4 SD]. 
Three of the four Anaplastic mixed tumors had stable disease. 
Ten responses were seen in the 18 GBM patients [4 PR, 6 SD]. 
Median response duration for the GBM patients is 24 weeks. 
Toxicities included 5 patients with grade 4 neutropenia, and 2 with grade 4 thrombocytopenia. 
One patient was hospitalized with neutropenic fever. 
Nonhematologic toxicity was gastrointestinal [N&V&D with abdominal cramps] which responded well to Atropine, Ativan, and Imodium and alopecia. 
The combination of Temozolomide and Irinotecan is active in recurrent malignant astrocytomas. 
More study is required to determine maximal dose. 
Scheduling of treatment, effect of anticonvulsants, and the use of cytokines in both newly diagnosed and recurrent malignant astrocytomas.

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