Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022256
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-08-10
Brief Title:
Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
An Open-Label Phase II Trial to Evaluate the Safety and Pharmacokinetics of Motexafin Gadolinium and Cranial Irradiation in the Treatment of Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2013-06
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 Drugs such as motexafin gadolinium may make tumor cells more sensitive to radiation therapy
PURPOSE Phase II trial to study the effectiveness of motexafin gadolinium plus radiation therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of motexafin gadolinium plus radiation therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES I Assess the safety of motexafin gadolinium and cranial irradiation in terms of dose-limiting toxicity and clinically significant adverse events in patients with newly diagnosed glioblastoma multiforme II Evaluate the pharmacokinetics of this regimen in these patients III Determine the survival of patients treated with this regimen IV Assess the activities of daily living and neurological status of patients treated with this regimen
OUTLINE This is a multicenter study Patients receive motexafin gadolinium IV over 30 minutes on days 1-5 of weeks 1 and 2 and on days 1 3 and 5 of weeks 3-6 Patients undergo cranial irradiation on days 1-5 of weeks 1-6 Treatment continues in the absence of disease progression or unacceptable toxicity Patients undergo a neurological examination and an activities of daily living questionnaire at baseline week 10 and during follow-up visits Patients are followed at weeks 10 and 16 and then every 2 months thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive motexafin gadolinium IV over 30 minutes on days 1-5 of weeks 1 and 2 and on days 1 3 and 5 of weeks 3-6 Patients undergo cranial irradiation on days 1-5 of weeks 1-6 Treatment continues in the absence of disease progression or unacceptable toxicity Patients undergo a neurological examination and an activities of daily living questionnaire at baseline week 10 and during follow-up visits Patients are followed at weeks 10 and 16 and then every 2 months thereafter
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| NCI-G01-1999 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068799 | REGISTRY | None | None |
| PCI-PCYC-0206 | None | None | None |