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

Primary Purpose

Head and Neck Cancer

Status

Terminated

Phase

Phase 1

Locations

Finland

Study Type

Interventional

Intervention

BNCT

cetuximab

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, boron neutron capture therapy, cetuximab, epidermal growth factor receptor, safety, efficacy, survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Oncology, Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BNCT plus cetuximab

Arm Description

Patients treated with BNCT followed by cetuximab administration

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Safety

Duration of treatment response

Time to progression

Survival

Adverse events

Full Information

NCT ID

NCT00927147

First Posted

June 21, 2009

Last Updated

January 30, 2017

Sponsor

Boneca Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00927147

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Terminated

Why Stopped

The neutron facility closed down for financial reasons.

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boneca Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

head and neck cancer, boron neutron capture therapy, cetuximab, epidermal growth factor receptor, safety, efficacy, survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BNCT plus cetuximab

Arm Type

Experimental

Arm Description

Patients treated with BNCT followed by cetuximab administration

Intervention Type

Radiation

Intervention Name(s)

BNCT

Intervention Description

Boronophenylalanine infusion followed by neutron irradiation

Intervention Type

Drug

Intervention Name(s)

cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

cetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions

Primary Outcome Measure Information:

Title

Response rate

Time Frame

December 2010

Secondary Outcome Measure Information:

Title

Safety

Time Frame

December 2010

Title

Duration of treatment response

Time Frame

December 2010

Title

Time to progression

Time Frame

December 2010

Title

Survival

Time Frame

December 2010

Title

Adverse events

Time Frame

December 2010

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heikki Joensuu, MD

Organizational Affiliation

Department of Oncology, Helsinki University Central Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Oncology, Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

FIN-00029

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

17689034

Citation

Kankaanranta L, Seppala T, Koivunoro H, Saarilahti K, Atula T, Collan J, Salli E, Kortesniemi M, Uusi-Simola J, Makitie A, Seppanen M, Minn H, Kotiluoto P, Auterinen I, Savolainen S, Kouri M, Joensuu H. Boron neutron capture therapy in the treatment of locally recurred head and neck cancer. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):475-82. doi: 10.1016/j.ijrobp.2007.03.039. Epub 2007 Aug 6.

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

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