- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114790
Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment Head and Neck Tumors
Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Inoperable and Irradiated Head and Neck Tumors: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single BNCT-facility, non-randomized, non-comparative, open-label, phase I to II trial to determine the value of BNCT in the treatment of inoperable, irradiated, locally advanced cancers of the head and neck region. An attempt to perform 18F-labeled boronophenylalanine (18F-BPA) SPECT or PET imaging will be made before BNCT. Patients whose tumor uptake is >2.5 times that of the corresponding normal head and neck tissue will be enrolled, and treated with a single fraction BPA-based BNCT twice, 3 to 5 weeks apart. Another 18F-BPA SPECT or PET study may be performed 1 to 3 months after BNCT to determine the SPECT/PET response.
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.
Prior to BNCT, BPA is infused as a fructose complex (l-BPA-F) into a peripheral vein over 2 hours. Blood samples will be taken for monitoring whole blood boron concentration before starting the BPA infusion, and thereafter at 20 to 40 minute intervals during the infusion, following infusion, and after delivering neutron irradiation. The blood samples will be analyzed for blood boron concentration to estimate the average blood boron concentration during neutron irradiation.
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
-
-
-
Helsinki, Finland, FIN-00029
- Department of Oncology, Helsinki University Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed, malignant head and neck cancer.
- Inoperable tumor, prior surgery may or may not have been done.
- Prior radiotherapy or chemoradiotherapy has been given.
- If prior SPECT or PET with 18F-BFA has been done, BPA needs to accumulate at least 2.5 times more in the tumor than in the corresponding contralateral normal tissue.
- WHO performance status <3.
- WBC >2,500/mm3, platelets >75,000/mm3, serum creatinine <180 umol/L.
- A written informed consent.
Exclusion Criteria:
- Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given.
- A non-experimental, effective treatment option is available.
- Expected survival less than 3 months.
- Concomitant systemic chemotherapy (prior cancer chemotherapy is allowed).
- Other concurrent experimental therapy, or such therapy is being planned to be given.
- Less than 3 months since prior radiation therapy.
- Untreated or severe, treated congestive heart failure or renal failure.
- 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 or the patient is not willing to participate in follow-up.
- Pregnancy.
- Age less than 18.
- The patient is not able to understand the treatment options.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BNCT.
Boronophenylalanine-based BNCT.
|
Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
treatment response
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety
Time Frame: 2 years
|
2 years
|
time to progression
Time Frame: 2 years
|
2 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.
- Porra L, Wendland L, Seppala T, Koivunoro H, Revitzer H, Tervonen J, Kankaanranta L, Anttonen A, Tenhunen M, Joensuu H. From Nuclear Reactor-Based to Proton Accelerator-Based Therapy: The Finnish Boron Neutron Capture Therapy Experience. Cancer Biother Radiopharm. 2022 Oct 21. doi: 10.1089/cbr.2022.0059. Online ahead of print.
- Kankaanranta L, Seppala T, Koivunoro H, Saarilahti K, Atula T, Collan J, Salli E, Kortesniemi M, Uusi-Simola J, Valimaki P, Makitie A, Seppanen M, Minn H, Revitzer H, Kouri M, Kotiluoto P, Seren T, Auterinen I, Savolainen S, Joensuu H. Boron neutron capture therapy in the treatment of locally recurred head-and-neck cancer: final analysis of a phase I/II trial. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):e67-75. doi: 10.1016/j.ijrobp.2010.09.057. Epub 2011 Feb 6.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN-BPA-01-2003
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.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on boronophenylalanine-based BNCT
-
The Third Xiangya Hospital of Central South UniversityBeijing Capture Technology Co., LtdUnknownMelanoma | Boron Neutron Capture TherapyChina
-
Southern Tohoku BNCT Research CenterActive, not recruitingHead and Neck Cancer | Squamous Cell CarcinomaJapan
-
Boneca CorporationCompletedGlioblastoma | Anaplastic AstrocytomaFinland
-
Beth Israel Deaconess Medical CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System Tumors | Metastatic Cancer | Melanoma (Skin)United States
-
Beth Israel Deaconess Medical CenterUnknownMelanoma (Skin)United States
-
European Organisation for Research and Treatment...Terminated
-
Taipei Veterans General Hospital, TaiwanNational Tsing Hua University,TaiwanUnknown
-
Stella Pharma CorporationCancer Intelligence Care Systems, Inc.RecruitingUnresectable AngiosarcomaJapan
-
European Organisation for Research and Treatment...CompletedHead and Neck Cancer | Colorectal Cancer | Metastatic CancerGermany
-
Boneca CorporationTerminated