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

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.

DISEASE CHARACTERISTICS:

- Diagnosis of supratentorial or infratentorial brain tumor

- Localized, non-disseminated

- Primary tumor or solitary metastasis

- Recurrent or progressive

- Unresectable

- Negative CSF

- Must have failed standard therapy including radiotherapy

- Measurable disease as evidenced by CT scan or MRI

- Single or multiple masses accessible to light administration

PATIENT CHARACTERISTICS:

Age:

- 3 to 70

Performance status:

- Not specified

Life expectancy:

- At least 2 months

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm3

- May transfuse platelets

Hepatic:

- PT and PTT normal

Renal:

- Not specified

Other:

- Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 6 weeks since prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior brachytherapy

Surgery:

- See Disease Characteristics

Other:

- No other concurrent antitumor therapy