ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004015
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: sodium borocaptate
Procedure: adjuvant therapy
Phase I

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration [ Designated as safety issue: Yes ]

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 [ Designated as safety issue: Yes ]
  • Overall survival as measured by Logrank until death [ Designated as safety issue: No ]

Estimated Enrollment:   36
Study Start Date:   June 2002

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.

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004015

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

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Investigator:     Wolfgang Sauerwein, MD, PhD     Universitaetsklinikum Essen    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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):392-399.
 
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.
 

Other Publications:
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.
 
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.
 
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.
 
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. Review.
 
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.
 
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.
 
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.
 

Study ID Numbers:   CDR0000067232, EORTC-11961
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004015
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma  
adult giant cell glioblastoma  
adult gliosarcoma  

Study placed in the following topic categories:
Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers