Boron Neutron Capture Therapy (BNCT) Combined With Cetuximab in the Treatment of Locally Recurred Head and Neck Cancer

This study has been terminated.
(The neutron facility closed down for financial reasons.)
Sponsor:
Information provided by (Responsible Party):
Boneca Corporation
ClinicalTrials.gov Identifier:
NCT00927147
First received: June 21, 2009
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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 recurred locally following conventional cancer treatment (surgery and radiation therapy). Boron neutron capture therapy is a special form of radiation therapy, which is based on interaction between boron atoms taken up by the cancerous tissue and neutron irradiation. The boron atoms, located within cancer cells, may capture low-energy neutrons obtained from a nuclear accelerator, which results in splitting up (fission) of the boron atoms, and a high radiation effect within the tumor. Cetuximab is an antibody directed against certain proteins found on cancer cell surface (epidermal growth factor receptors). When administered immediately after BNCT, cetuximab may or may not improve treatment efficacy.


Condition Intervention Phase
Head and Neck Cancer
Radiation: BNCT
Drug: cetuximab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Boneca Corporation:

Primary Outcome Measures:
  • Response rate [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
  • Duration of treatment response [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BNCT plus cetuximab
Patients treated with BNCT followed by cetuximab administration
Radiation: BNCT
Boronophenylalanine infusion followed by neutron irradiation
Drug: cetuximab
cetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions
Other Name: Erbitux

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927147

Locations
Finland
Department of Oncology, Helsinki University Central Hospital
Helsinki, Finland, FIN-00029
Sponsors and Collaborators
Boneca Corporation
Investigators
Study Chair: Heikki Joensuu, MD Department of Oncology, Helsinki University Central Hospital
  More Information

Publications:
Responsible Party: Boneca Corporation
ClinicalTrials.gov Identifier: NCT00927147     History of Changes
Other Study ID Numbers: HN-BPA-01-2008
Study First Received: June 21, 2009
Last Updated: May 3, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Boneca Corporation:
head and neck cancer
boron neutron capture therapy
cetuximab
epidermal growth factor receptor
safety
efficacy
survival

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014