BNCT to Treat Glioma That Has Progressed Following Radiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00115440|
Recruitment Status : Completed
First Posted : June 23, 2005
Last Update Posted : January 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Anaplastic Astrocytoma||Radiation: Bononophenylalanine (BPA)-based BNCT||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BPA-Mediated Boron Neutron Capture Therapy (BNCT) in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||January 2009|
Active treatment arm.
Radiation: Bononophenylalanine (BPA)-based BNCT
Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
- safety [ Time Frame: 3 years ]
- survival [ Time Frame: 3 years ]
- adverse effects of BNCT [ Time Frame: 3 years ]
- quality-of-life [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115440
|Department of Oncology, Helsinki University Central Hospital|
|Helsinki, Finland, FIN-00029|
|Principal Investigator:||Heikki T Joensuu, M.D., prof.||Helsinki University Central Hospital|