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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Unknown status

CT.gov ID

NCT00002647

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Metastatic Cancer	Drug: verteporfin Procedure: conventional surgery	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Primary Purpose:

Treatment

Official Title:

Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

Study Start Date :

May 1, 1994

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
2	Midwest Children's Cancer Center at Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226