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.

Condition	Treatment or Intervention	Phase
adult brain tumor brain metastases childhood brain stem glioma childhood brain tumor childhood cerebellar astrocytoma childhood visual pathway and hypothalamic glioma	Drug: benzoporphyrin derivative monoacid ring A  Procedure: conventional surgery  Procedure: laser therapy  Procedure: photodynamic therapy  Procedure: phototherapy  Procedure: surgery	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  3 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of supratentorial or infratentorial brain tumor
• Localized, non-disseminated
• Primary 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

Wisconsin
      Children's Hospital of Wisconsin, Milwaukee,  Wisconsin,  53201,  United States; Recruiting
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Study chairs or principal investigators

Harry T. Whelan, MD,  Study Chair,  Medical College of Wisconsin   

Study ID Numbers:  CDR0000064165; MCW-7594; MCW-CHW-511; MCW-CHW-9411; NCI-V95-0652; NCT00002647
Record last reviewed:  July 2002
Last Updated:  March 3, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002647
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08