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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00004015

Collaborator

(none)

Enrollment

Locations

4.5

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: sodium borocaptate Procedure: adjuvant therapy	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Primary Purpose:

Treatment

Official Title:

Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Jul 1, 2003

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karl-Franzens-University Graz	Graz		Austria	A-8010
2	Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
3	Hopital Pasteur	Nice		France	06002
4	Universitaetsklinikum Essen	Essen		Germany	D-45122
5	Klinikum der Universitaet Muenchen - Grosshadern Campus	Munich		Germany	D-81377
6	Ospedale Santa Chiara Pisa	Pisa		Italy	56100
7	Vrije Universiteit Medisch Centrum	Amsterdam		Netherlands	1007 MB
8	EC Joint Research Centre - Institute for Energy	Petten		Netherlands	NL-1755 ZG