Head and Neck Cancer Clinical Trial
Official title:
Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Inoperable and Irradiated Head and Neck Tumors: A Feasibility Study
Verified date | May 2013 |
Source | Boneca Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is based on the principle of irradiating boron atoms with neutrons. When neutrons have relatively low energy, boron atoms that have been targeted to cancerous tissue using a suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will capture the neutrons. As a result from the neutron capture the boron atoms will split into two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor. In practice, the study participants will receive BPA as an approximately 2-hour intravenous infusion, following which the tumor is irradiated with low energy (epithermal) neutrons obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose planning, but neutron irradiation will last approximately only for one hour. In this study BNCT will be repeated, and the 2 treatments will be given 3 to 5 weeks apart. The study hypothesis is that head and neck cancers that have recurred following conventional radiotherapy might accumulate the boron carrier compound, and might respond to BNCT.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2012 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed, malignant head and neck cancer. - Inoperable tumor, prior surgery may or may not have been done. - Prior radiotherapy or chemoradiotherapy has been given. - If prior SPECT or PET with 18F-BFA has been done, BPA needs to accumulate at least 2.5 times more in the tumor than in the corresponding contralateral normal tissue. - WHO performance status <3. - WBC >2,500/mm3, platelets >75,000/mm3, serum creatinine <180 umol/L. - A written informed consent. Exclusion Criteria: - Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given. - A non-experimental, effective treatment option is available. - Expected survival less than 3 months. - Concomitant systemic chemotherapy (prior cancer chemotherapy is allowed). - Other concurrent experimental therapy, or such therapy is being planned to be given. - Less than 3 months since prior radiation therapy. - Untreated or severe, treated congestive heart failure or renal failure. - A cardiac pace-maker or an unremovable metal implant 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. - The patient is not able to understand the treatment options. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Department of Oncology, Helsinki University Central Hospital | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Boneca Corporation |
Finland,
Joensuu H, Kankaanranta L, Seppälä T, Auterinen I, Kallio M, Kulvik M, Laakso J, Vähätalo J, Kortesniemi M, Kotiluoto P, Serén T, Karila J, Brander A, Järviluoma E, Ryynänen P, Paetau A, Ruokonen I, Minn H, Tenhunen M, Jääskeläinen J, Färkkilä M, Savolainen S. Boron neutron capture therapy of brain tumors: clinical trials at the finnish facility using boronophenylalanine. J Neurooncol. 2003 Mar-Apr;62(1-2):123-34. — View Citation
Kouri M, Kankaanranta L, Seppälä T, Tervo L, Rasilainen M, Minn H, Eskola O, Vähätalo J, Paetau A, Savolainen S, Auterinen I, Jääskeläinen J, Joensuu H. Undifferentiated sinonasal carcinoma may respond to single-fraction boron neutron capture therapy. Radiother Oncol. 2004 Jul;72(1):83-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | treatment response | 1 year | No | |
Secondary | time to progression | 2 years | No | |
Secondary | safety | 2 years | Yes |
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