Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003909
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
1999-11-01
Brief Title:
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Motexafin Gadolinium Xcytrin NSC 695238 and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose MTD and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma
II Determine the toxic effects of this drug given at the MTD in these patients
III Determine the intratumor and brain distribution of this drug by magnetic resonance imaging MRI in these patients
OUTLINE This is a dose-escalation study of motexafin gadolinium
Approximately 2-5 hours before radiotherapy patients receive motexafin gadolinium IV over 5 minutes Patients undergo radiotherapy 5 days a week for 6 weeks
Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the MTD is determined The first cohort receives motexafin gadolinium 5 days a week for 3 weeks the second cohort receives motexafin gadolinium 3 days a week for 6 weeks and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for up to 3 years
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study within 2 years
I Determine the maximum tolerated dose MTD and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma
II Determine the toxic effects of this drug given at the MTD in these patients
III Determine the intratumor and brain distribution of this drug by magnetic resonance imaging MRI in these patients
OUTLINE This is a dose-escalation study of motexafin gadolinium
Approximately 2-5 hours before radiotherapy patients receive motexafin gadolinium IV over 5 minutes Patients undergo radiotherapy 5 days a week for 6 weeks
Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the MTD is determined The first cohort receives motexafin gadolinium 5 days a week for 3 weeks the second cohort receives motexafin gadolinium 3 days a week for 6 weeks and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for up to 3 years
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| COG-A09712 | None | None | None |
| U01CA097452 | NIH | None | None |
| CDR0000067087 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA097452 |