DISEASE CHARACTERISTICS:
- Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic
brainstem glioma
- Greater than 50% intra-axial involvement of the pons, pons and medulla, pons and
midbrain, or entire brainstem
- Contiguous involvement of the thalamus or upper cervical cord allowed
PATIENT CHARACTERISTICS:
Age:
- 21 and under
Performance status:
- ECOG 0-2
Life expectancy:
- More than 2 months
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL (transfusion allowed)
- No glucose 6 phosphate dehydrogenase deficiency
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT or SGPT less than 1.5 times normal
Renal:
- Creatinine no greater than 1.5 times normal OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunomodulating agents
Chemotherapy:
- No other concurrent chemotherapy
Endocrine therapy:
- Concurrent corticosteroid therapy allowed for increased intracranial pressure only
Radiotherapy:
- No prior cranial radiotherapy
Surgery:
- Not specified
Other:
- No prior motexafin gadolinium
- No other concurrent experimental agents
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium
administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic
pontine glioma.
- Determine the toxic effects of this drug given at the MTD in these patients.
- Determine the intratumor and brain distribution of this drug by MRI in these patients.
OUTLINE: This is a dose-escalation study of motexafin gadolinium.
Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5
minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the maximum
tolerated dose (MTD) is determined. The first cohort receives motexafin gadolinium 5 days a
week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks;
and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity.
Patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
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