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

Metastatic Cancer Clinical Trial

Official title:

A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039572
• Other study ID #: BIDMC-E-010284FB
• Secondary ID: CDR0000069398NED
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 6, 2002
• Last updated: June 25, 2013
• Start date: May 2002
• Est. completion date: January 2005

Study information

• Verified date: July 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Melanoma
• Melanoma (Skin)
• Metastatic Cancer
• Neoplasm Metastasis
• Nervous System Neoplasms

Intervention

Drug:
• boronophenylalanine-fructose complex

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts Institute of Technology	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,