BPA-Mediated Boron Neutron Capture Therapy (BNCT) in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy
18 Years
N/A
Both
Glioblastoma, Anaplastic Astrocytoma
Trial Information
BPA-Mediated Boron Neutron Capture Therapy (BNCT) in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy
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).
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
safety
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Heikki T Joensuu, M.D., prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Helsinki University Central Hospital
Authority:
Finland: Finnish Medicines Agency
Study ID:
FIN-BNCT-03/2000
NCT ID:
NCT00115440
Start Date:
March 2001
Completion Date:
January 2009
Related Keywords:
- Glioblastoma
- Anaplastic Astrocytoma
- glioblastoma
- anaplastic astrocytoma
- boron neutron capture therapy
- radiation therapy
- boronophenylalanine
- Astrocytoma
- Glioblastoma
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