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. - BNCT and cetuximab in the treatment of head and neck cancer

Conditions: ocally recurred, advanced head and neck cancer

Registration Number: EUCTR2008-004751-30-FI

Lead Sponsor: Boneca Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Histologically confirmed invasive squamous cell carcinoma of the head and neck.
2.Inoperable tumor or the patient is not a candi-date for surgery for medical reasons; prior sur-gery may or may not have been done.
3.Prior radiotherapy or chemoradiotherapy has been given to the tumor.
4.If prior SPECT or PET with 18F-BFA has been done, BPA need to accumulate at least 2 times more in the tumor than in the corresponding normal tissue.
5.A written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Presence of distant metastases.
2.A non-experimental, effective treatment op-tion is available.
3.WHO performance status >3.
4.WBC <2,500/mm3, platelets <75,000/mm3, serum creatinine >180 *mol/L.
5.Concomitant systemic cancer chemotherapy (except cetuximab).
6.Other concurrent experimental therapy, or such therapy is being planned to be given.
7.Less than 1 month since prior radiation ther-apy.
8.Untreated or severe treated congestive heart failure or renal failure.
9.A cardiac pace-maker or unremovable metal implants present in the head and neck region that will interfere with MRI-based dose-planning.
10.Restlessness or inability to lie in a cast for 30 to 60 minutes.
11.Clinical follow-up after therapy cannot be ar-ranged or the patient is not willing to partici-pate in follow-up.
12.Pregnancy.
13.Age less than 18.
14.The patient is not able to understand the treatment options.
15.Known allergy/hypersensitivity to cetuximab.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase I part: To assess safety of cetuximab administered immediately af-ter boronophenylalanine (BPA)-based boron neutron capture therapy (BNCT) in the treatment of inoperable, irradiated head and neck carcinoma.<br>Phase II part: To assess response rate to the combination of BPA-based BNCT and cetuximab. <br>;Secondary Objective: To assess duration of response, time to cancer progression, time to locoregional progression, overall survival, adverse effects, and quality of life (QOL). ;Primary end point(s): •Safety of treatment <br>•Response rate<br>

Secondary Outcome Measures