Glioma Clinical Trial
Official title:
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
This is an open-label, multicenter, phase II trial, assessing the antitumor activity, and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
This open-label, multicenter, phase II trial will assess the antitumor activity and safety
of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic
glioma.
Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be
enrolled in this study. Total accrual on this study will not exceed 116 patients. The
patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus
infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning
immediately after the first bolus infusion and continuing until immediately prior to the
last bolus injection. Patients will be evaluated for AEs during the course of therapy.
Patients may receive treatment at the same dose level until appearance of significant
treatment-related toxicities, disease progression or withdrawal of consent.
Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles
for the duration of therapy, using physical and neurological examinations and diagnostic
imaging.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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