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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2002 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on June 6, 2002. Last Updated on August 29, 2009 History of Changes

Sponsor:	Beth Israel Deaconess Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00039572

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors Melanoma (Skin) Metastatic Cancer	Drug: boronophenylalanine-fructose complex	Phase I Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Fructose

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039572

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Paul M. Busse, MD, PhD

Beth Israel Deaconess Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00039572 History of Changes
Other Study ID Numbers:	CDR0000069398, BIDMC-E-010284FB, NEDH-E-010284FB, NCI-V02-1702
Study First Received:	June 6, 2002
Last Updated:	August 29, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
stage IV melanoma
tumors metastatic to brain
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroendocrine Tumors
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012