Status:
COMPLETED
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Untreated Childhood Brain Stem Glioma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
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 ...
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 (br...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00387790
Start Date
June 1 2007
End Date
April 1 2010
Last Update
January 4 2018
Active Locations (1)
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1
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104