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

Primary Purpose

Brain and Central Nervous System Tumors, Metastatic Cancer

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

verteporfin

conventional surgery

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical College of Wisconsin Cancer CenterRecruiting
Midwest Children's Cancer Center at Children's Hospital of WisconsinRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002647

First Posted

November 1, 1999

Last Updated

September 19, 2013

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT00002647

Brief Title

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

Official Title

Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 1994 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

verteporfin

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harry T. Whelan, MD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Study Chair

Facility Information:

Facility Name

Medical College of Wisconsin Cancer Center

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Office - Medical College of Wisconsin Cancer C

Phone

414-805-4380

Facility Name

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

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruce A. Kaufman, MD

Phone

414-266-2000

12. IPD Sharing Statement

Citations:

PubMed Identifier

8837808

Citation

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.

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

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