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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
O6BG + Temozolomide
AOI Pharmaceuticals Investigative Site
Los Angeles, California, United States
AOI Pharmaceuticals Investigative Site
Orlando, Florida, United States
AOI Pharmaceuticals Investigative Site
Chicago, Illinois, United States
best objective response rate
Time frame: Month 1, 2 and every 2 months thereafter.
Safety Assessment
Time frame: Month 1, 2 and every 2 months thereafter
progression-free survival
Time frame: every 6 months
overall survival
Time frame: every 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AOI Pharmaceuticals Investigative Site
Evanston, Illinois, United States
AOI Pharmaceuticals Investigative Site
Lexington, Kentucky, United States
AOI Pharmaceuticals Investigative Site
Louisville, Kentucky, United States
AOI Pharmaceuticals Investigative Site
Minneapolis, Minnesota, United States
AOI Pharmaceuticals Investigative Site
Durham, North Carolina, United States
AOI Pharmaceuticals Investigative Site
Greenville, South Carolina, United States
AOI Pharmaceuticals Investigative Site
Dallas, Texas, United States
...and 2 more locations