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| 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 |
| 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.
Eligibility| 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:
Contacts and 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 | |
| Investigator: | Wolfgang Sauerwein, MD, PhD | Universitaetsklinikum Essen |
More Information
| 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 |