Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma

NCT ID: NCT00387790

Last Updated: 2018-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-04-30

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.

Conditions

Untreated Childhood Brain Stem Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

motexafin gadolinium

Intervention Type: DRUG

Given IV

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Undergo focal cranial radiotherapy

Interventions

motexafin gadolinium

Given IV

Intervention Type: DRUG

3-dimensional conformal radiation therapy

Undergo focal cranial radiotherapy

Intervention Type: RADIATION

Other Intervention Names

gadolinium texaphyrin; Gd (III) Texaphryin; Gd-Tex; PCI-0120; Xcytrin; 3D conformal radiation therapy; 3D-CRT

Eligibility Criteria

Inclusion Criteria

• Diagnosis of intrinsic pontine glioma (brain stem glioma)

• Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically [> 50% intra-axial] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
• Tumor may contiguously involve the thalamus or upper cervical cord
• No more than 1 lesion/mass present at diagnosis
• Karnofsky performance status (PS) 60-100% (age > 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
• Life expectancy ≥ 8 weeks
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³ (transfusion independent)
• Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT < 1.5 times ULN
• No known glucose-6-phosphate dehydrogenase (G6PD) deficiency

• If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
• No biliary obstruction
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior definitive therapy for this specific tumor
• No prior cranial radiotherapy
• Concurrent steroids and anticonvulsants allowed
• No concurrent proton therapy
• No concurrent intensity-modulated radiotherapy
• No concurrent anticancer chemotherapy
• No concurrent immunomodulating agents

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Bradley

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Children's Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-01829

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000504107

Identifier Type: -

Identifier Source: secondary_id

COG-ACNS0222

Identifier Type: -

Identifier Source: secondary_id

ACNS0222

Identifier Type: OTHER

Identifier Source: secondary_id

ACNS0222

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01829

Identifier Type: -

Identifier Source: org_study_id