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

Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002647
Enrollment
24
Registered
2003-01-27
Start date
1994-05-31
Completion date
Unknown
Last updated
2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors, Metastatic Cancer

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

Brief 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.

Interventions

DRUGverteporfin
PROCEDUREconventional surgery

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026