Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004146
Status:
COMPLETED
Last Update Posted:
2015-05-08
First Post:
1999-12-10
Brief Title:
Carboxyamidotriazole RT in Treating Patients Newly Diagnosed Supratentorial GBM
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI Carboxy-Amido Triazole in Adults With Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate overall survival rate in patients administered CAI carboxyamidotriazole and radiation therapy to adults with newly diagnosed glioblastoma multiforme
II To determine the toxicity of CAI when combined with cranial irradiation III To estimate correlations between pharmacokinetic parameters including steady state CAI concentration with toxicity andor drug activity in this patient population
IV To estimate duration of disease free progression with this treatment regime
OUTLINE This is a multicenter study
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity Patients are followed monthly for survival
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study over 15 years
I To evaluate overall survival rate in patients administered CAI carboxyamidotriazole and radiation therapy to adults with newly diagnosed glioblastoma multiforme
II To determine the toxicity of CAI when combined with cranial irradiation III To estimate correlations between pharmacokinetic parameters including steady state CAI concentration with toxicity andor drug activity in this patient population
IV To estimate duration of disease free progression with this treatment regime
OUTLINE This is a multicenter study
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity Patients are followed monthly for survival
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study over 15 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-03011 | REGISTRY | None | None |
| CDR67378 | None | None | None |
| NABTT-9904 | OTHER | None | None |
| NABTT-9904 | OTHER | None | None |
| U01CA062475 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062475 |