Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	3 to 70	Other	MCW-7594 MCW-CHW-511, MCW-CHW-9411, NCI-V95-0652, NCT00002647

Objectives

1. Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
2. Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients.

Entry 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

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

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

Expected Enrollment

A minimum of 24 patients will be accrued for this study within 3 years.

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.

Schmidt MH, Bajic DM, Reichert KW 2nd, et al.: Light-emitting diodes as a light source for intraoperative photodynamic therapy. Neurosurgery 38 (3): 552-6; discussion 556-7, 1996.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical College of Wisconsin Cancer Center

Harry Whelan, MD, Protocol chair		Ph: 414-266-7544 Email: hwhelan@mcw.edu

U.S.A.
Wisconsin
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
	Midwest Children's Cancer Center at Children's Hospital of Wisconsin
		Bruce Kaufman, MD	Ph:  414-266-2000

Registry Information
Official Title		Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
Trial Start Date		1994-05-01
Registered in ClinicalTrials.gov		NCT00002647
Date Submitted to PDQ		1995-04-14
Information Last Verified		2009-06-07

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