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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00039572
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Beth Israel Deaconess Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Paul M. Busse, MD, PhD
Principal Investigator Affiliation Beth Israel Deaconess Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Melanoma (Skin), Metastatic Cancer
Additional Details

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.

Contact a Trial Team

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Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Massachusetts Institute of Technology, Cambridge, Massachusetts

Status

Address

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139

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