- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00927147
Boron Neutron Capture Therapy (BNCT) Combined With Cetuximab in the Treatment of Locally Recurred Head and Neck Cancer
Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) Combined With Anti-erbB1 Antibody Therapy in the Treatment of Locally Recurred Head and Neck Cancer: A Phase I/II Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, non-randomized, non-comparative, open-label, phase I/II trial to determine safety and efficacy of BNCT in the treatment of nonoperable, irradiated, locally advanced cancers of the head and neck region. Patients will be treated with a single-fraction boronophenylalanine (BPA)-based BNCT. All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).
Neutron irradiation will first be planned based on the available tumor imaging examinations, following which the head and body position will be determined for irradiation, and head fixation will be prepared and tested. On the irradiation day 400 mg/m2 L-BPA-F will be infused intravenously over 2 hours. Cetuximab doses will be administered following completion of BNCT. The cetuximab doses will be escalated in cohorts of 3 patients.
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 invasive squamous cell carcinoma of the head and neck
- Inoperable tumor or the patient is not a candidate for surgery for medical reasons; prior surgery may or may not have been done
- Prior radiotherapy or chemoradiotherapy has been given to the tumor
- If prior 18F-boronophenylalanine (BPA) PET (positron emission tomography)has been done, BPA needs to accumulate at least 2 times more in the tumor than in the corresponding normal tissue
- A written informed consent
Exclusion Criteria:
- Presence of distant metastases
- A non-experimental, effective treatment op-tion is available
- WHO performance status >3
- WBC <2,500/mm3, platelets <75,000/mm3, serum creatinine >180 umol/L
- Concomitant systemic cancer chemotherapy (except cetuximab).
- Other concurrent experimental therapy
- Less than 1 month since prior radiation therapy
- Untreated or severe treated congestive heart failure or renal failure
- A cardiac pace-maker or unremovable metal implants 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
- Known allergy/hypersensitivity to cetuximab
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 plus cetuximab
Patients treated with BNCT followed by cetuximab administration
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Boronophenylalanine infusion followed by neutron irradiation
cetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: December 2010
|
December 2010
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: December 2010
|
December 2010
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Duration of treatment response
Time Frame: December 2010
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December 2010
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Time to progression
Time Frame: December 2010
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December 2010
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Survival
Time Frame: December 2010
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December 2010
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Adverse events
Time Frame: December 2010
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December 2010
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Heikki Joensuu, MD, Department of Oncology, Helsinki University Central Hospital
Publications and helpful links
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
- HN-BPA-01-2008
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
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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
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on BNCT
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Taipei Veterans General Hospital, TaiwanNational Tsing Hua University,TaiwanUnknown
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Boneca CorporationCompletedHead and Neck CancerFinland
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Boneca CorporationCompletedGlioblastoma | Anaplastic AstrocytomaFinland
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Centre Hospitalier Universitaire, AmiensCompletedPneumonia | AntibioticsFrance