Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
NCT ID: NCT00004015
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2002-06-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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sodium borocaptate
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Wolfgang Sauerwein, MD, PhD
Role: STUDY_CHAIR
Universitaetsklinikum Essen
Locations
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Karl-Franzens-University Graz
Graz, , Austria
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Hopital Pasteur
Nice, , France
Universitaetsklinikum Essen
Essen, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, , Germany
Ospedale Santa Chiara Pisa
Pisa, , Italy
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
EC Joint Research Centre - Institute for Energy
Petten, , Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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. doi: 10.1259/bjr.71.843.9616243.
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.
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.
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. doi: 10.1007/BF02699941.
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):392-9. doi: 10.1016/j.ijrobp.2004.06.008.
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 Identifiers
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EORTC-11961
Identifier Type: -
Identifier Source: secondary_id
EORTC-11961
Identifier Type: -
Identifier Source: org_study_id