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

Beth Israel Lahey Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Cancer; Brain and Central Nervous System Tumors; Melanoma (Skin)

Treatments: Drug: boronophenylalanine-fructose complex

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00039572

CDR0000069398 (Registry Identifier)

NCI-V02-1702

BIDMC-E-010284FB

NEDH-E-010284FB

Details and patient eligibility

About

RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.

Full description

OBJECTIVES:

• 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.
• Determine the maximum tolerated dose of cranial neutron capture therapy in these patients.
• Determine, through serial objective measurements, the clinical response in patients treated with this therapy.
• Determine the pharmacokinetics of BPA-f in these patients.

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.

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior cranial irradiation

Surgery:

• Not specified