search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
sodium borocaptate
adjuvant therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Karl-Franzens-University Graz
  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
  • Hopital Pasteur
  • Universitaetsklinikum Essen
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Ospedale Santa Chiara Pisa
  • Vrije Universiteit Medisch Centrum
  • EC Joint Research Centre - Institute for Energy

Outcomes

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

Full Information

First Posted
November 1, 1999
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
search

1. Study Identification

Unique Protocol Identification Number
NCT00004015
Brief Title
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
Official Title
Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sodium borocaptate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration
Secondary Outcome Measure Information:
Title
Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death
Title
Overall survival as measured by Logrank until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Sauerwein, MD, PhD
Organizational Affiliation
Universitaetsklinikum Essen
Official's Role
Study Chair
Facility Information:
Facility Name
Karl-Franzens-University Graz
City
Graz
ZIP/Postal Code
A-8010
Country
Austria
Facility Name
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Hopital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern Campus
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Ospedale Santa Chiara Pisa
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
EC Joint Research Centre - Institute for Energy
City
Petten
ZIP/Postal Code
NL-1755 ZG
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16362787
Citation
Wittig A, Moss RL, Stecher-Rasmussen F, Appelman K, Rassow J, Roca A, Sauerwein W. Neutron activation of patients following boron neutron capture therapy of brain tumors at the high flux reactor (HFR) Petten (EORTC Trials 11961 and 11011). Strahlenther Onkol. 2005 Dec;181(12):774-82. doi: 10.1007/s00066-005-1433-4.
Results Reference
background
PubMed Identifier
11996055
Citation
Verbakel WF, Hideghety K, Morrissey J, Sauerwein W, Stecher-Rasmussen F. Towards in vivo monitoring of neutron distributions for quality control of BNCT. Phys Med Biol. 2002 Apr 7;47(7):1059-72. doi: 10.1088/0031-9155/47/7/305.
Results Reference
background
PubMed Identifier
11746321
Citation
Husing J, Sauerwein W, Hideghety K, Jockel KH. A scheme for a dose-escalation study when the event is lagged. Stat Med. 2001 Nov 30;20(22):3323-34. doi: 10.1002/sim.954.
Results Reference
background
PubMed Identifier
11295213
Citation
Rassow J, Stecher-Rasmussen F, Voorbraak W, Moss R, Vroegindeweij C, Hideghety K, Sauerwein W. Comparison of quality assurance for performance and safety characteristics of the facility for Boron Neutron Capture therapy in Petten/NL with medical electron accelerators. Radiother Oncol. 2001 Apr;59(1):99-108. doi: 10.1016/s0167-8140(00)00298-x.
Results Reference
background
PubMed Identifier
10394415
Citation
Sauerwein W, Moss R, Rassow J, Stecher-Rasmussen F, Hideghety K, Wolbers JG, Sack H. Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961).EORTC BNCT study group. Strahlenther Onkol. 1999 Jun;175 Suppl 2:108-11. doi: 10.1007/BF03038906.
Results Reference
background
PubMed Identifier
9525503
Citation
Gabel D, Philipp KH, Wheeler FJ, Huiskamp R. The compound factor of the 10B(n,alpha)7Li reaction from borocaptate sodium and the relative biological effectiveness of recoil protons for induction of brain damage in boron neutron capture therapy. Radiat Res. 1998 Apr;149(4):378-86.
Results Reference
background
PubMed Identifier
9616243
Citation
Pignol JP, Oudart H, Chauvel P, Sauerwein W, Gabel D, Prevot G. Selective delivery of 10B to soft tissue sarcoma using 10B-L-borophenylalanine for boron neutron capture therapy. Br J Radiol. 1998 Mar;71(843):320-3. doi: 10.1259/bjr.71.843.9616243.
Results Reference
background
PubMed Identifier
12573762
Citation
Verbakel WF, Sauerwein W, Hideghety K, Stecher-Rasmussen F. Boron concentrations in brain during boron neutron capture therapy: in vivo measurements from the phase I trial EORTC 11961 using a gamma-ray telescope. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):743-56. doi: 10.1016/s0360-3016(02)04392-4.
Results Reference
result
PubMed Identifier
10394416
Citation
Hideghety K, Sauerwein W, Haselsberger K, Grochulla F, Fankhauser H, Moss R, Huiskamp R, Gabel D, de Vries M. Postoperative treatment of glioblastoma with BNCT at the petten irradiation facility (EORTC protocol 11,961). Strahlenther Onkol. 1999 Jun;175 Suppl 2:111-4. doi: 10.1007/BF03038907.
Results Reference
result
Citation
Gabel D, Touw D, Stecher-Rasmussen F, et al.: Quality control of Na2B12H11SH, a drug boron neutron capture therapy in EORTC trial 11961. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.
Results Reference
result
PubMed Identifier
12749710
Citation
Hideghety K, Sauerwein W, Wittig A, Gotz C, Paquis P, Grochulla F, Haselsberger K, Wolbers J, Moss R, Huiskamp R, Fankhauser H, de Vries M, Gabel D. Tissue uptake of BSH in patients with glioblastoma in the EORTC 11961 phase I BNCT trial. J Neurooncol. 2003 Mar-Apr;62(1-2):145-56. doi: 10.1007/BF02699941.
Results Reference
result
Citation
Hideghety W, Sauerwein W, DeVries M, et al.: Post-operative treatment of glioblastoma with boron neutron capture therapy at the European High Flux Reactor Petten (EORTC protocol 11961). [Abstract] Ann Oncol 9(suppl 2): 129, 1998.
Results Reference
result
Citation
Sauerwein W, Hideghety K, De Vries M, et al.: Boron neutron capture therapy (BNCT) for the treatment of glioblastoma (EORTC protocol 11961). [Abstract] Radiother Oncol 48(suppl 1): s157, 1998.
Results Reference
result
Citation
Sauerwein W, Hideghety K, De Vries M, et al.: Conducting phase I clinical trial in binary treatment modality: methodical questions for the evaluation of boron neutron capture therapy. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.
Results Reference
result
PubMed Identifier
15667958
Citation
Vos MJ, Turowski B, Zanella FE, Paquis P, Siefert A, Hideghety K, Haselsberger K, Grochulla F, Postma TJ, Wittig A, Heimans JJ, Slotman BJ, Vandertop WP, Sauerwein W. Radiologic findings in patients treated with boron neutron capture therapy for glioblastoma multiforme within EORTC trial 11961. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):392-9. doi: 10.1016/j.ijrobp.2004.06.008.
Results Reference
result
Citation
Haselsberger K, Pendl G, Sauerwein W, et al.: BNCT for glioblastoma in Europe: design of the EORTC protocol 11961 and clinical course of the first patient. [Abstract] J Neurooncol 39 (2): A-P155, 147, 1998.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs