Viewing Study NCT00387790



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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

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