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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

Conditions
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Brain and Central Nervous System Tumors, Metastatic Cancer

Intervention / Treatment
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* Drug: verteporfin
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: verteporfin|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult brain stem glioma, recurrent childhood pineoblastoma, recurrent adult brain tumor, tumors metastatic to brain, recurrent childhood brain stem glioma, recurrent childhood anaplastic astrocytoma, recurrent childhood anaplastic oligoastrocytoma, recurrent childhood anaplastic oligodendroglioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood diffuse astrocytoma, recurrent childhood fibrillary astrocytoma, recurrent childhood gemistocytic astrocytoma, recurrent childhood giant cell glioblastoma, recurrent childhood glioblastoma, recurrent childhood gliomatosis cerebri, recurrent childhood gliosarcoma, recurrent childhood oligodendroglioma, recurrent childhood pilocytic astrocytoma, recurrent childhood pilomyxoid astrocytoma, recurrent childhood pleomorphic xanthoastrocytoma, recurrent childhood protoplasmic astrocytoma, recurrent childhood subependymal giant cell astrocytoma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood visual pathway glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood medulloblastoma, recurrent childhood ependymoma, recurrent childhood brain tumor, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic meningioma, adult anaplastic oligodendroglioma, adult central nervous system germ cell tumor, adult choroid plexus tumor, adult craniopharyngioma, adult diffuse astrocytoma, adult ependymoblastoma, adult ependymoma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult medulloblastoma, meningeal melanocytoma, adult meningeal hemangiopericytoma, adult oligodendroglioma, adult papillary meningioma, adult pilocytic astrocytoma, adult pineal gland astrocytoma, adult pineoblastoma, adult pineocytoma, adult subependymal giant cell astrocytoma, adult subependymoma, adult supratentorial primitive neuroectodermal tumor (PNET), childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, adult grade III meningioma, childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood craniopharyngioma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, childhood low-grade cerebral astrocytoma, childhood high-grade cerebral astrocytoma