Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Conditions
Brain and Central Nervous System Tumors - Metastatic Cancer
Conditions: official terms
Brain Neoplasms - Central Nervous System Neoplasms - Neoplasm Metastasis - Nervous System Neoplasms
Conditions: Keywords
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 pineoblastoma, 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 brain stem glioma, 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
Study Type
Interventional
Study Phase
Phase 1
Study Design
Primary Purpose: Treatment
Intervention
Name: verteporfin Type: Drug
Name: conventional surgery Type: Procedure
Overall Status
Recruiting
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 3 Years
Gender: Both
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
Locations
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C - 414-805-4380
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Bruce A. Kaufman, MD - 414-266-2000
Start Date
May 1994
Sponsors
Medical College of Wisconsin
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page