Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003409
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose Escalating Study of the Safety and Tolerability of Gadolinium Texaphyrin as a Radiation Sensitizer in Patients With Primary Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2007-06
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation
PURPOSE Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine the safety and tolerability of motexafin gadolinium in combination with radiotherapy in patients with newly diagnosed glioblastoma multiforme II Determine the intratumoral pharmacology and quantitative pharmacokinetics of this drug in this patient population
OUTLINE This is a multicenter dose-escalation study of motexafin gadolinium Patients receive a loading dose regimen comprising motexafin gadolinium IV over 10-15 minutes on days 1-5 or days 1-5 and 8-12 cohort 7 After the loading dose regimen patients receive a maintenance regimen comprising motexafin gadolinium IV 3 times weekly for a maximum of 65 weeks Patients also undergo radiotherapy once daily 5 days a week for 65 weeks Cohorts of 3-6 patients receive an escalating number of doses of motexafin gadolinium until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A maximum of 35 patients will be accrued for this study
OUTLINE This is a multicenter dose-escalation study of motexafin gadolinium Patients receive a loading dose regimen comprising motexafin gadolinium IV over 10-15 minutes on days 1-5 or days 1-5 and 8-12 cohort 7 After the loading dose regimen patients receive a maintenance regimen comprising motexafin gadolinium IV 3 times weekly for a maximum of 65 weeks Patients also undergo radiotherapy once daily 5 days a week for 65 weeks Cohorts of 3-6 patients receive an escalating number of doses of motexafin gadolinium until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A maximum of 35 patients will be accrued for this study
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 |
|---|---|---|---|
| UCLA-HSPC-970904203 | None | None | None |
| COOPER-RP-97-126 | None | None | None |
| LAC-USC-6G971 | None | None | None |
| UCD-RW-98-01 | None | None | None |
| UCLA-HSPC-970904201 | None | None | None |
| UCLA-HSPC-970904202 | None | None | None |
| NCI-T97-0108 | None | None | None |