Status:
TERMINATED
Boron Neutron Capture Therapy (BNCT) Combined With Cetuximab in the Treatment of Locally Recurred Head and Neck Cancer
Lead Sponsor:
Boneca Corporation
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to investigate efficacy and safety boron neutron capture therapy (BNCT) administered in combination with cetuximab in the treatment of head and neck cancer that has recurre...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00927147
Start Date
June 1 2009
End Date
June 1 2013
Last Update
January 31 2017
Active Locations (1)
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1
Department of Oncology, Helsinki University Central Hospital
Helsinki, Finland, FIN-00029