Locally recurred, advanced head and neck cancer
Conditions
Interventions
Product Name: boronophenylalanine
Product Code: BPA-f
Pharmaceutical Form: Powder for infusion*
Trade Name: Erbitux
Product Name: Erbitux
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN
Sponsors
Boneca Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Presence of distant metastases. 2. A non-experimental, effective treatment op-tion is available. 3. WHO performance status >3. 4. WBC 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Phase II part: To assess response rate to the combination of BPA-based BNCT and cetuximab. ;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 • Response rate | — |
Countries
Finland
Outcome results
None listed