Head and Neck CancerPhase 1/2NCT00927147
Boron Neutron Capture Therapy (BNCT) Combined With Cetuximab in the Treatment of Locally Recurred Head and Neck Cancer
A Phase 1/2 study testing BNCT and cetuximab in people with Head and Neck Cancer, run by Boneca Corporation at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- BNCT and cetuximab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2009to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Oncology, Helsinki University Central Hospital
Helsinki, FIN-00029
About this study
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.
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- BNCT, cetuximab
- Keywords
- head and neck cancer, boron neutron capture therapy, cetuximab, epidermal growth factor receptor, safety, efficacy, survival
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNCTRadiation
Boronophenylalanine infusion followed by neutron irradiation
cetuximabDrug
Also called Erbitux
cetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions
| Study group | Role | What they receive |
|---|---|---|
| BNCT plus cetuximab | Experimental | Patients treated with BNCT followed by cetuximab administration Receives: Radiation: BNCT; Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: December 2010
Secondary outcomes (5)
Safety
Measured: December 2010
Duration of treatment response
Measured: December 2010
Time to progression
Measured: December 2010
Survival
Measured: December 2010
Adverse events
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: The neutron facility closed down for financial reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boneca Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heikki Joensuu, MD, Study chair, Department of Oncology, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927147
- Sponsor's protocol ID
- HN-BPA-01-2008
- Status last verified
- Jan 2017
- First submitted
- 21 Jun 2009
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17689034
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00927147
- Acronym / sponsor ID
- HN-BPA-01-2008
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, boron neutron capture therapy, cetuximab, epidermal growth factor receptor, safety, efficacy, survival
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The neutron facility closed down for financial reasons.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Boneca CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNCT plus cetuximab | Experimental | Radiation: BNCT, Drug: cetuximabPatients treated with BNCT followed by cetuximab administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNCTBoronophenylalanine infusion followed by neutron irradiation | Radiation | BNCT plus cetuximab |
| cetuximabAlso: Erbituxcetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions | Drug | BNCT plus cetuximab |
Primary outcome
Response rate
Time frame: December 2010
5 secondary outcomes
Safety
Time frame: December 2010
Duration of treatment response
Time frame: December 2010
Time to progression
Time frame: December 2010
Survival
Time frame: December 2010
Adverse events
Time frame: December 2010
Results and safety
The study was stopped early (reason given: The neutron facility closed down for financial reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Background: PubMed 17689034Kankaanranta 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki Joensuu, MD study chair
Department of Oncology, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BNCT and cetuximab in people with Head and Neck Cancer, run by Boneca Corporation at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The neutron facility closed down for financial reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: December 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.