Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	21 and under at diagnosis	NCI	COG-ACNS0222 ACNS0222, NCT00387790

Objectives

Primary

1. 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

1. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients.
2. Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• 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

Patient Characteristics:

• 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

Expected Enrollment

A total of 60 patients will be accrued for this study.

Outcomes

Event-free survival, defined as time to disease progression, disease relapse, occurrence of second neoplasm, or death from any cause at 1 year

Overall survival, defined as time to death from any cause at 1 year
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Kristin Bradley, MD, Protocol chair		Ph: 608-263-8500; 800-622-8922

Registry Information
Official Title		A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
Trial Start Date		2007-06-04
Trial Completion Date		2009-01-24 (estimated)
Registered in ClinicalTrials.gov		NCT00387790
Date Submitted to PDQ		2006-08-14
Information Last Verified		2008-10-31
NCI Grant/Contract Number		CA98543

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