Clinical Trial: A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Keryx / AOI Pharmaceuticals, Inc.

Current Primary Outcome: best objective response rate [ Time Frame: Month 1, 2 and every 2 months thereafter. ]

Original Primary Outcome:

  • best objective response rate
  • occurrence of treatment related AEs


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • best overall response
  • progression-free survival
  • overall survival


Information By: Keryx / AOI Pharmaceuticals, Inc.

Dates:
Date Received: October 16, 2006
Date Started: October 2006
Date Completion:
Last Updated: February 7, 2012
Last Verified: February 2012