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Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

2014-08-27 03:59:02 | BioPortfolio

Summary

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.

Description

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.

Study Design

Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

verteporfin, conventional surgery

Location

Medical College of Wisconsin Cancer Center
Milwaukee
Wisconsin
United States
53226

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:02-0400

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