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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Untreated Childhood Brain Stem Glioma

Treatments

Drug: motexafin gadolinium

Radiation: 3-dimensional conformal radiation therapy

Study type

Interventional

Funder types

NIH

Identifiers

NCT00387790

CDR0000504107

ACNS0222 (Other Identifier)

U10CA098543 (U.S. NIH Grant/Contract)

NCI-2012-01829 (Registry Identifier)

COG-ACNS0222

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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