Completed

Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

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What is being tested

sodium borocaptate

+ adjuvant therapy

DrugProcedure
Who is being recruted

Astrocytoma+12

+ Glioma

+ Neoplasms

Over 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2002
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: July 18, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2002

Actual date on which the first participant was enrolled.

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.

NCT00004015
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: July 18, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialGlioblastomaCentral Nervous System NeoplasmsGliosarcoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Karl-Franzens-University Graz

Graz, AustriaOpen Karl-Franzens-University Graz in Google Maps

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

Toronto, Canada

Hopital Pasteur

Nice, France

Universitaetsklinikum Essen

Essen, Germany
Completed8 Study Centers