Status:
COMPLETED
BNCT to Treat Glioma That Has Progressed Following Radiotherapy
Lead Sponsor:
Boneca Corporation
Conditions:
Glioblastoma
Anaplastic Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is based on the principle of irradiating boron atoms with neutrons. When neutrons have relatively low energy, ...
Detailed Description
This is a single BNCT-facility, non-randomized, non-comparative, prospective, open-label, phase I/II study to determine the value of BNCT in the treatment of inoperable, irradiated, progressing anapla...
Eligibility Criteria
Inclusion
- Histologically confirmed supratentorial glioblastoma or anaplastic astrocytoma.
- Recurred tumor after surgery and radiotherapy or tumor progressing after radiotherapy.
- Recurrence/progression has been confirmed by serial MRI scans and a biopsy, or by debulking surgery.
- The World Health Organization performance status \<2.
- WBC \>2,500/mm3, platelet count \>75,000/mm3, serum creatinine \<180 umol/L.
- A written informed consent
Exclusion
- Age less than 18
- Tumor infiltrates into the brain stem or the optic tracts
- The majority of tumor tissue consists of grade II glioma with only a focal grade III component
- A minimum gross tumor dose of 17 Gy (W) is not obtained in dose-planning
- Less than 6 months has elapsed from the last date of external irradiation
- Less than 4 weeks has elapsed from the last cancer chemotherapy dose prior to giving BNCT
- The total conventional radiation therapy dose given is more than 61 Gy or less than 50 Gy, or one of nonconventional fractionation schemes has been used (conventional: 1.8-2.0 Gy/day, 5 days per week, weekly dose 9 to 10 Gy)
- More than approximately 1/3 of the total brain volume has been within the 90% isodose
- Gliomas where the enhancing tumor volume is larger than 2/3 of the volume of one hemisphere in the MRI examination preceding BNCT
- More than one radiotherapy course has been given to the brain tumor
- Untreated congestive heart failure or renal failure
- Uncontrolled brain oedema despite the use of corticosteroids
- A cardiac pace-maker or an unremovable metal implant present in the head and neck region that will interfere with MRI-based dose-planning
- Restlessness or inability to lie in a cast for 30 to 60 minutes
- Clinical follow-up after therapy cannot be arranged
- Pregnancy
- Inability to understand treatment options
- Unwillingness to take part in the follow-up schedule
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00115440
Start Date
March 1 2001
End Date
January 1 2009
Last Update
January 28 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Oncology, Helsinki University Central Hospital
Helsinki, Finland, FIN-00029