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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004015 |
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 |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility |
Estimated Enrollment: | 36 |
Study Start Date: | June 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
Investigator: | Wolfgang Sauerwein, MD, PhD | Universitaetsklinikum Essen |
Study ID Numbers: | CDR0000067232, EORTC-11961 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004015 History of Changes |
Health Authority: | United States: Federal Government |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Neuroectodermal Tumors Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Adjuvants, Immunologic Neuroepithelioma |
Glioblastoma Multiforme Glioma Central Nervous System Neoplasms Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |