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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Tsing Hua University,Taiwan
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01173172
First received: July 28, 2010
Last updated: July 30, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Radiation: Boron Neutron Capture Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Boron Neutron Capture Therapy (BNCT) for Recurrent Head and Neck Cancer at Tsing-Hua Open Pool Reactor

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Treatment toxicities and response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    CTC ver 4 for toxicities RECIST for response


Secondary Outcome Measures:
  • Time to tumor progression [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Change of quality of life [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    Health-related quality of life will be measured before and after BNCT at regular intervals


Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BNCT, recurrent head and neck cancer
Single arm treated by BNCT only
Radiation: Boron Neutron Capture Therapy
Boronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30)

Detailed Description:

This is a prospective, single arm, open label phase I/II trial with boron neutron capture (BNCT) therapy for patients with previously irradiated and locally recurrent head and neck cancer.

The eligibility criteria are patients with locoregionally recurrent head and neck cancer; good performance status; inoperable, clinical measurable tumor size; good organ function and good compliance. No systemic treatment is in use. Once entering this study, patients will receive angiographies to evaluate bloody supply of the tumor and PET scan with 18F-fluoro-L-BPA as the tracer. Tumor-to- normal tissue ratios were evaluated from static emission scans. Boron concentration of normal tissues is derived from measurement of BPA concentration in the blood. Treatment planning with THORplan will be done after Computerized Tomography (CT) simulation. After treatment plan approved and on the day of treatment, intravenous or intra-arterial L-BPA- Fructose complex 500 mg/kg was administered at a constant rate over about 3 hours before and during neutron irradiation. Neutron beam irradiations were given at the THOR with prescription dose of 20 to 25 Gy (Eq) for the tumor in one fraction on day 1 and repeated on day 30. Patients will be regularly followed up at OPD for toxicities (NCI Common Terminology Criteria) and response evaluation (RECIST criteria)by MRI and PET, time to progression measurement, survival status and change of quality of life. Maximally 27 patients will be enrolled. After first 10 patients, the preliminary results will be reviewed before further patients' enrollment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173172

Contacts
Contact: Ling-Wei Wang, MD 886-2-28757270 ext 308 lwwang@vghtpe.gov.tw
Contact: Sang-Hue Yen, MD 886-2-28757015 shyen@vghtpe.gov.tw

Locations
Taiwan
Cancer Center, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Principal Investigator: Ling-Wei Wang, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Tsing Hua University,Taiwan
Investigators
Principal Investigator: Ling-Wei Wang, MD Cancer Center, Veterans General Hospital-Taipei, Taiwan
  More Information

No publications provided

Responsible Party: Ling-Wei Wang/Chief, Division of Radiotherapy, Cancer Center, Cancer Center, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01173172     History of Changes
Other Study ID Numbers: BNCT_090514
Study First Received: July 28, 2010
Last Updated: July 30, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Boron neutron capture therapy (BNCT)
Head and neck cancer
toxicities
response rate

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Boron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014