Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387790
Status:
COMPLETED
Last Update Posted:
2018-01-04
First Post:
2006-10-12
Brief Title:
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Motexafin-Gadolinium NSC 695238 IND 55583 and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
Status:
COMPLETED
Status Verified Date:
2017-12
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:
This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma Radiation therapy uses high-energy x-rays to kill tumor cells Drugs such as motexafin gadolinium may make tumor cells more sensitive to radiation therapy Giving motexafin gadolinium together with radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma brain stem glioma
SECONDARY OBJECTIVES
I Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients
II Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients
OUTLINE This is a multicenter study
Patients receive motexafin gadolinium IV over 5-10 minutes once daily prior to radiotherapy 5 days a week for 6 weeks Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years and then periodically thereafter
I Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma brain stem glioma
SECONDARY OBJECTIVES
I Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients
II Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients
OUTLINE This is a multicenter study
Patients receive motexafin gadolinium IV over 5-10 minutes once daily prior to radiotherapy 5 days a week for 6 weeks Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years and then periodically thereafter
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 |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2012-01829 | REGISTRY | None | None |
| CDR0000504107 | None | None | None |
| COG-ACNS0222 | None | None | None |
| ACNS0222 | OTHER | None | None |
| ACNS0222 | OTHER | None | None |