- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115440
BNCT to Treat Glioma That Has Progressed Following Radiotherapy
BPA-Mediated Boron Neutron Capture Therapy (BNCT) in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy
Study Overview
Status
Conditions
Intervention / Treatment
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 anaplastic astrocytomas or glioblastomas following conventional radiation therapy. The neutron irradiation site is the FiR 1 reactor site, located at Otaniemi, Espoo, Finland, about 6 kilometers from the Helsinki University Central Hospital, Helsinki, where patient evaluation and post-irradiation care will take place.
BPA is infused as a fructose complex (BPA-F) into a peripheral vein over 2 hours prior to neutron irradiation. Blood samples will be taken before starting the BPA infusion, and thereafter at 20 to 40 minute intervals during the infusion, following infusion, and after delivering neutron irradiation to monitor the blood boron concentration. The blood samples will be analyzed for boron to estimate the average blood boron level during neutron irradiation. A minimum tumor dose of 17 Gy (W) is given while limiting the normal brain maximum peak dose to 8 Gy (W), and the average normal brain dose to 6 Gy (W). The first 10 patients will be given BPA 290 mg/kg, following which the BPA dose will be escalated in cohorts of 3 subjects gradually up to 450 mg/kg, provided that protocol-specified unacceptable toxicity will not occur.
All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Helsinki, Finland, FIN-00029
- Department of Oncology, Helsinki University Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Active treatment arm.
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Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival
Time Frame: 3 years
|
3 years
|
adverse effects of BNCT
Time Frame: 3 years
|
3 years
|
quality-of-life
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heikki T Joensuu, M.D., prof., Helsinki University Central Hospital
Publications and helpful links
General Publications
- Kouri M, Kankaanranta L, Seppala T, Tervo L, Rasilainen M, Minn H, Eskola O, Vahatalo J, Paetau A, Savolainen S, Auterinen I, Jaaskelainen J, Joensuu H. Undifferentiated sinonasal carcinoma may respond to single-fraction boron neutron capture therapy. Radiother Oncol. 2004 Jul;72(1):83-5. doi: 10.1016/j.radonc.2004.03.016.
- Joensuu H, Kankaanranta L, Seppala T, Auterinen I, Kallio M, Kulvik M, Laakso J, Vahatalo J, Kortesniemi M, Kotiluoto P, Seren T, Karila J, Brander A, Jarviluoma E, Ryynanen P, Paetau A, Ruokonen I, Minn H, Tenhunen M, Jaaskelainen J, Farkkila M, Savolainen S. Boron neutron capture therapy of brain tumors: clinical trials at the finnish facility using boronophenylalanine. J Neurooncol. 2003 Mar-Apr;62(1-2):123-34. doi: 10.1007/BF02699939.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIN-BNCT-03/2000
- BNCT P-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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