Boron Neutron Capture Therapy (BNCT) for Locally Recurrent Head and Neck Cancer

NCT01173172 | Completed Phase 1 DMC

• 1 other identifier: BNCT_090514
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a boron neutron capture (BNCT) therapy for patients with previously irradiated and locally recurrent head and neck cancer. The primary end points are treatment toxicities and response rate. The secondary endpoints are time to tumor progression, progression-free survival, overall survival and change quality of life. Head and neck carcinomas that recur locally after conventional irradiation pose a therapeutic challenge. Boron neutron capture therapy (BNCT) is based on the nuclear capture reaction that occurs when non-radioactive boron is irradiated with neutrons of thermal energy to yield high energy alpha particles and recoiling lithium nuclei. The effect of alpha and 7Li is primarily limited to boron- containing cells. Preferential uptake of boron into cancerous tissue is achieved using boron carriers such as a derivative of phenylalanine, boronophenylalanine (BPA). After administration of BPA by an intra-arterial or intravenous infusion, the tumor site is irradiated with neutrons, the source of which is currently a nuclear reactor. A few uncontrolled clinical trials have evaluated BNCT in the treatment of glioblastoma after brain surgery. In these studies, the median survival times have been 13-15 months after BNCT. However, efficacy and tolerability of BNCT in the treatment of limited number of head and neck cancer patients showed promising results. Though many basic researches about BNCT has been done using Tsing Hua Open-pool Reactor (THOR) at National Tsing Hua University, no clinical trial utilizing BNCT is performed in our country. This study will be the first BNCT trial to treat head and neck cancer in Taiwan.

Conditions

Head and Neck Cancer

Keywords

Boron neutron capture therapy (BNCT); Head and neck cancer; toxicities; response rate

Outcome Measures

Primary Outcomes (1)

• Treatment toxicities and response rate

  CTC ver 4 for toxicities RECIST for response

  2 years

Secondary Outcomes (4)

• Time to tumor progression

  5 year

• Progression-free survival

  5 years

• overall survival

  5 year

• Change of quality of life

  2 year

Study Arms (1)

BNCT, recurrent head and neck cancer

EXPERIMENTAL

Single arm treated by BNCT only

Radiation: Boron Neutron Capture Therapy

Interventions

Boron Neutron Capture Therapy RADIATION

Boronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30)

BNCT, recurrent head and neck cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with locoregionally recurrent, histologically proved malignancy of the head and neck.
• Prior conventional radiotherapy administered has been given for the disease (except melanoma) and surgery, conventional radiotherapy or chemotherapy are not appropriate for salvage.
• Bi-dimensionally measurable disease by MRI and/or CT scan and ≦ 12 cm in largest dimension.
• Age greater than 18 years and \< 80 years, ECOG performance status ≦ 2
• WBC \> 2.5 x109/L, neutrophil count \>1.0 x109/L, platelet count \>75x109/L, serum creatinine \<1.25xULN.
• Informed consent signed.
• Tumor to Normal tissue (T/N) ratio for BPA \>2.5 by 18F-BPA PET scan.

You may not qualify if:

• 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.
• Patients who had an effective standard treatment option available.
• Distant metastasis outside of the head and neck region.
• Expecting life less than 3 months.
• A time interval less than 3 months from previous radiation therapy.
• Concurrent systemic cancer treatment including chemotherapy or target therapy.
• Severe congestive heart failure or renal failure.
• Pregnancy.
• Restless patients who were unable to lie or sit in a cast for 30-60 min.
• A cardiac pace-maker or an unremovable metal implant present in the head and neck region that will interfere with MRI-based dose-planning or tumor response evaluation.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Tsing Hua University,Taiwan: collaborator

Study Sites (1)

Cancer Center, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Boron Neutron Capture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Neutron Capture Therapy; Radiotherapy, High-Energy; Radiotherapy; Therapeutics

Study Officials

• Ling-Wei Wang, MD

  Cancer Center, Veterans General Hospital-Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 30, 2010
• Study Start: July 1, 2010
• Primary Completion: March 7, 2014
• Study Completion: March 7, 2015
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

TW (1)