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

Completed · Phase 2

Conditions studied: Untreated Childhood Brain Stem Glioma

In brief

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.

Key facts

Study ID

NCT00387790

Run by

National Cancer Institute (NCI)

People needed

64

Starts

2007-06-01

Expected to finish

2010-04-01

Last updated by the study team

2018-01-04

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Children's Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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