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

Alternate Title

Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI	BIDMC-E-010284FB NEDH-E-010284FB, NCI-V02-1702, NCT00039572

Objectives

1. Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility.
2. Determine the maximum tolerated dose of cranial neutron capture therapy in these patients.
3. Determine, through serial objective measurements, the clinical response in patients treated with this therapy.
4. Determine the pharmacokinetics of BPA-f in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed glioblastoma multiforme

  OR

• Radiographically diagnosed brain metastases after a diagnosis of melanoma
• Contrast-enhanced tumor volume must not exceed 60 mL

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior cranial irradiation

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 6 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine normal

Cardiovascular:

• No prior severe cardiac disease, including the following:
  • Uncontrolled arrhythmias or conduction defects
  • Unstable or newly diagnosed angina pectoris
  • Recent coronary artery disease
  • Congestive heart failure

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 6 months after study
• No prior phenylketonuria
• No cognitive impairment that would preclude informed consent

Expected Enrollment

A total of 16 patients will be accrued for this study within 2 years.

Outline

This is a dose-escalation study of cranial neutron capture therapy (NCT).

Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2.

Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.

Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years.

Trial Contact Information

Trial Lead Organizations

Beth Israel Deaconess Medical Center

Paul Busse, MD, PhD, Protocol chair		Ph: 617-667-2345

Registry Information
Official Title		A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
Trial Start Date		2002-05-13
Registered in ClinicalTrials.gov		NCT00039572
Date Submitted to PDQ		2002-04-30
Information Last Verified		2002-07-31
NCI Grant/Contract Number		R21-CA94617

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