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Home > "B" Clinical Trials Conditions > Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery  Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): EORTC Boron Neutron Capture Therapy Study Group ,
Synopsis: RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: Phase I trial to study the effectiveness of boron neutron capture therapy following surgery in treating patients who have glioblastoma multiforme removed during surgery.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WolfgangSauerwein, , Universitaetsklinikum Essen
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Wolfgang Sauerwein 49-201-723-2052
EC Joint Research Centre - Institute for Energy *Recruiting*
Petten, , NL-1755 ZG
Netherlands
Recruiting Ray Moss 0031-224-565126
Karl-Franzens-University Graz *Recruiting*
Graz, , A-8010
Austria
Recruiting Klaus Haselsberger 316-385-2708
Hopital Pasteur *Recruiting*
Nice, , 06002
France
Recruiting Philippe Paquis 33-92-03-8450
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Jean-Philippe Pignol 416-480-6100 ext. 5767
Vrije Universiteit Medisch Centrum *Recruiting*
Amsterdam, , 1007 MB
Netherlands
Recruiting Jan Jacob 31-20-444-0414
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen *Recruiting*
Munich, , D-81377
Germany
Recruiting Claudia Goetz 49-7095-2591
Ospedale Santa Chiara *Recruiting*
Pisa, , 56100
Italy
Recruiting Luca Cionini 39-050-992-540
Additional Information:
Study ID Numbers: CDR0000067232; EORTC-11961
Study Start Date:
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004015
Other Adult Glioblastoma Multiforme Studies:
1. Irinotecan in Treating Patients With Recurrent Malignant Glioma
2. Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma
3. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
4. Oxaliplatin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
5. Sirolimus in Treating Patients With Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Clinical Trials
Other Petten Clinical Trials
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
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