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

NCT00004015 | Completed Phase 1

• 1 other identifier: EORTC-11961
• Study Type: interventional
• Target: 36
• Locations: 6 countries
• Sites: 8

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

sodium borocaptate DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (8)

Karl-Franzens-University Graz

Graz, A-8010, Austria

Location

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Hopital Pasteur

Nice, 06002, France

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Ospedale Santa Chiara Pisa

Pisa, 56100, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

Location

EC Joint Research Centre - Institute for Energy

Petten, NL-1755 ZG, Netherlands

Location

Related Publications (16)

• 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.

  PMID: 16362787 BACKGROUND

• 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.

  PMID: 11996055 BACKGROUND

• 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.

  PMID: 11746321 BACKGROUND

• 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.

  PMID: 11295213 BACKGROUND

• 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.

  PMID: 10394415 BACKGROUND

• 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.

  PMID: 9525503 BACKGROUND

• 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.

  PMID: 9616243 BACKGROUND

• 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.

  PMID: 12573762 RESULT

• 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.

  PMID: 10394416 RESULT

• 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.

  RESULT

• 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.

  PMID: 12749710 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 15667958 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

mercaptoundecahydrododecaborate; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Wolfgang Sauerwein, MD, PhD

  Universitaetsklinikum Essen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: July 1, 2003
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

AU (1); FR (1); IT (1); NL (2); DE (2); CA (1)