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Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

Study Purpose

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

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 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically proven glioblastoma multiforme for which conventional radiotherapy would be of little or no benefit.
  • - Gross total resection of tumor confirmed by postoperative MRI performed within 48 hours of surgery.
  • - Evaluable preoperative and postoperative MRI films with and without contrast must be available.
  • - No prior brain malignancy.
  • - No prior craniotomy except for glioblastoma.
PATIENT CHARACTERISTICS: Age:
  • - 50 and over.
Performance status:
  • - Karnofsky 70-100% Life expectancy: - Not specified.
Hematopoietic:
  • - Not specified.
Hepatic:
  • - Bilirubin, SGOT, SGPT, and alkaline phosphatase no greater than 2.5 times normal unless caused by reversible reaction to antiseizure medication.
Renal:
  • - Blood urea nitrogen and creatinine no greater than 2.5 times upper limit of normal.
Cardiovascular:
  • - No severe heart disease (e.g., congestive heart failure, angina pectoris) Pulmonary: - No severe dyspnea at time of diagnosis.
  • - No severe obstructive or restrictive lung disease.
Other:
  • - No other concurrent malignant tumor.
  • - No severe gastrointestinal disease or active peptic ulcer disease.
  • - No uncontrolled endocrine disease.
  • - No serious mental disease, organic brain disease (e.g., preexisting epilepsy or serious aphasia), or legally incapacitated patients.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - No prior biologic therapy for glioblastoma multiforme.
  • - No concurrent biologic therapy.
Chemotherapy:
  • - No prior chemotherapy for glioblastoma multiforme.
  • - No concurrent chemotherapy.
Endocrine therapy:
  • - No prior endocrine therapy for glioblastoma multiforme except corticosteroids.
  • - No concurrent endocrine therapy.
Radiotherapy:
  • - See Disease Characteristics.
  • - No prior radiotherapy for glioblastoma multiforme.
  • - No prior radiotherapy to head and neck.
  • - No other concurrent radiotherapy.
Surgery:
  • - See Disease Characteristics.
- Prior stereotactic biopsy allowed for glioblastoma multiforme

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.

NCT00004015
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
Lead Sponsor

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

European Organisation for Research and Treatment of Cancer - EORTC
Principal Investigator

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

Wolfgang Sauerwein, MD, PhD
Principal Investigator Affiliation Universitaetsklinikum Essen
Agency Class

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

Other
Overall Status Completed
Countries Austria, Canada, France, Germany, Italy, Netherlands
Conditions

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

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy (BNCT) following craniotomy with gross total resection in patients with glioblastoma multiforme.
  • - Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients.
  • - Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions.
OUTLINE: This is a dose escalation, multicenter study. Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation. Treatment repeats daily for 4 days. Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity. Patients are followed weekly for 4 weeks, monthly for 2 months, every 6 weeks for 15 months and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Karl-Franzens-University Graz, Graz, Austria

Status

Address

Karl-Franzens-University Graz

Graz, , A-8010

Toronto, Ontario, Canada

Status

Address

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5

Hopital Pasteur, Nice, France

Status

Address

Hopital Pasteur

Nice, , 06002

Universitaetsklinikum Essen, Essen, Germany

Status

Address

Universitaetsklinikum Essen

Essen, , D-45122

Munich, Germany

Status

Address

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, , D-81377

Ospedale Santa Chiara Pisa, Pisa, Italy

Status

Address

Ospedale Santa Chiara Pisa

Pisa, , 56100

Vrije Universiteit Medisch Centrum, Amsterdam, Netherlands

Status

Address

Vrije Universiteit Medisch Centrum

Amsterdam, , 1007 MB

Petten, Netherlands

Status

Address

EC Joint Research Centre - Institute for Energy

Petten, , NL-1755 ZG