A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
18 Years
N/A
Both
Brain and Central Nervous System Tumors, Melanoma (Skin), Metastatic Cancer
Trial Information
A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Paul M. Busse, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Federal Government
Study ID:
BIDMC-E-010284FB
NCT ID:
NCT00039572
Start Date:
May 2002
Completion Date:
January 2005
Related Keywords:
- Brain and Central Nervous System Tumors
- Melanoma (Skin)
- Metastatic Cancer
- adult glioblastoma
- stage IV melanoma
- tumors metastatic to brain
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Melanoma
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Massachusetts Institute of Technology | Cambridge, Massachusetts 02139 |
