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

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8010
        • Karl-Franzens-University Graz
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
  • France
      • Nice, France, 06002
        • Hopital PASTEUR
  • Germany
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen
      • Munich, Germany, D-81377
        • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Italy
      • Pisa, Italy, 56100
        • Ospedale Santa Chiara Pisa
  • Netherlands
      • Amsterdam, Netherlands, 1007 MB
        • Vrije Universiteit Medisch Centrum
      • Petten, Netherlands, NL-1755 ZG
        • EC Joint Research Centre - Institute for Energy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration

Secondary Outcome Measures

Outcome Measure
Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death
Overall survival as measured by Logrank until death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Wolfgang Sauerwein, MD, PhD, Universitaetsklinikum Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-11961

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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