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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.


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

December 2010

Safety Issue:

No

Principal Investigator

Heikki Joensuu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oncology, Helsinki University Central Hospital

Authority:

Finland: Finnish Medicines Agency

Study ID:

HN-BPA-01-2008

NCT ID:

NCT00927147

Start Date:

June 2009

Completion Date:

June 2014

Related Keywords:

  • Head and Neck Cancer
  • head and neck cancer
  • boron neutron capture therapy
  • cetuximab
  • epidermal growth factor receptor
  • safety
  • efficacy
  • survival
  • Head and Neck Neoplasms

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