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

NCT ID: NCT00002647

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-05-31

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.

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

verteporfin

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Principal Investigators

Harry T. Whelan, MD

Role: STUDY_CHAIR

Medical College of Wisconsin

Locations

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Clinical Trials Office - Medical College of Wisconsin Cancer C

Role: primary

Bruce A. Kaufman, MD

Role: primary

References

Schmidt MH, Bajic DM, Reichert KW 2nd, Martin TS, Meyer GA, Whelan HT. Light-emitting diodes as a light source for intraoperative photodynamic therapy. Neurosurgery. 1996 Mar;38(3):552-6; discussion 556-7. doi: 10.1097/00006123-199603000-00025.

Reference Type: BACKGROUND

PMID: 8837808 (View on PubMed)

Other Identifiers

MCW-7594

Identifier Type: -

Identifier Source: secondary_id

MCW-CHW-511

Identifier Type: -

Identifier Source: secondary_id

MCW-CHW-9411

Identifier Type: -

Identifier Source: secondary_id

NCI-V95-0652

Identifier Type: -

Identifier Source: secondary_id

CDR0000064165

Identifier Type: -

Identifier Source: org_study_id