Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389090
Status:
TERMINATED
Last Update Posted:
2012-02-09
First Post:
2006-10-16
Brief Title:
A Phase II Study of Temozolomide and O6-Benzylguanine O6-BG in Patients With Temozolomide-Resistant Anaplastic Glioma
Sponsor:
Keryx AOI Pharmaceuticals Inc
Organization:
Keryx AOI Pharmaceuticals Inc
Study Overview
Official Title:
A Phase II Study of Temozolomide and O6-Benzylguanine O6-BG in Patients With Temozolomide-Resistant Anaplastic Glioma
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
AOI Pharma terminated the license agreement IND Transferred to NCI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None