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

Metastatic Cancer Clinical Trial

Official title:

Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00002647
• Other study ID #: CDR0000064165
• Secondary ID: MCW-7594MCW-CHW-
• Status: Recruiting
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: May 1994

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 70 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Brain Neoplasms
• Central Nervous System Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Nervous System Neoplasms

Intervention

Drug:
• verteporfin

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Midwest Children's Cancer Center at Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation