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

Medical College of Wisconsin

Status and phase: Unknown; Phase 1

Conditions: Metastatic Cancer; Brain and Central Nervous System Tumors

Treatments: Drug: verteporfin; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00002647

MCW-CHW-9411

NCI-V95-0652

MCW-CHW-511

MCW-7594

CDR0000064165

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 3 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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