Metastatic Cancer Clinical Trial
Official title:
Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells
and may be an effective treatment for refractory brain tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic
therapy using porfimer sodium in treating patients with refractory brain tumors, including
astrocytoma, ependymoma, and medulloblastoma.
OBJECTIVES:
- Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with
refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
- Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes,
and survival of these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor
location (posterior fossa tumors vs all other brain tumors).
Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3
hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the
tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor
resection.
Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of
3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are
treated at the MTD.
Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1
year, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.
;
Primary Purpose: Treatment
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