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

NCT00039572 | Completed Phase 1

• 4 other identifiers: BIDMC-E-010284FBCDR0000069398NEDH-E-010284FBNCI-V02-1702
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain and Central Nervous System Tumors; Melanoma (Skin); Metastatic Cancer

Keywords

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

Interventions

boronophenylalanine-fructose complex DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Melanoma; Neoplasm Metastasis; Glioblastoma; Brain Neoplasms; Gliosarcoma

Interventions

4-boronophenylalanine-fructose

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Brain Diseases; Central Nervous System Diseases

Study Officials

• Paul M. Busse, MD, PhD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Study Completion: January 1, 2005
• Last Updated: June 26, 2013

Record last verified: 2002-07

Locations

US (2)