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

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00039572

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

32.1

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Melanoma (Skin) Metastatic Cancer	Drug: boronophenylalanine-fructose complex	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Massachusetts Institute of Technology	Cambridge	Massachusetts	United States	02139