Melanoma Clinical Trial
Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
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.
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
Boston Massachusetts, 02215, United States
Cambridge Massachusetts, 02139, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.