Clinical trial NCT02759536: In-hospital Neutron Irradiator (IHNI)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Malignant Melanoma
Official title: In-hospital Neutron Irradiator (IHNI)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Malignant Melanoma: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Melanoma
Boron Neutron Capture Therapy
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Beijing Capture Technology Co., Ltd
First posted: 2016-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Boron Neutron Capture Therapy (BNCT) has been used in the treatment of several types of malignant tumors, including malignant melanoma, high-grade gliomas, and advanced head and neck cancers. Theoretically, it represents a more precise radiotherapy in that it could spare normal cells while destroy malignant ones. However, its value is largely restricted by the fact that it could only be performed in the nuclear research reactors, the only neutron source at the time. In 2010, the world's first in-hospital neutron irradiator (IHNI) had been constructed in Beijing, China, and this study aims to evaluate whether IHNI has the potential to serve as an effective in-hospital neutron source for BNCT.

Detailed description: This is a single BNCT-facility, non-randomized, non-comparative, open-label, phase I to II clinical trial to determine the value of IHNI in the performance of BNCT. Before patients are recruited in this study, they must have been confirmed as malignant melanoma by biopsy and pathological analysis. Then they will receive a boron bio-distribution test, only patients whose boron concentration in tumor tissue is \>1.5 times that in the blood will be enrolled. Before patients being irradiated in IHNI, they will be infused Boronophenylalanine (BPA)-fructose solution intravenously at a dose of 350mg/kg over 90 minutes, and then blood will be withdrawn from the patient at different time points to measure boron concentration. The start point and duration of irradiation will be determined based on the boron concentration in blood and the boron bio-distribution curve.

IHNI locates in Fangshan District, Beijing, China. The recruitment of patients, and their evaluation and medical care before and after BNCT will be done in the Third Xiangya Hospital, Changsha, China.

All patients will be evaluated for response by biopsy and pathological analysis, Positron Emission Computed Tomography (PET-CT), Computed Tomography (CT) or magnetic resonance imaging (MRI).

Eligibility criteria: Inclusion Criteria:

1. Sign an informed consent form.
2. Age above 18, gender unlimited.
3. Expectation of life above 3 months.
4. Characteristic of disease: ① Pathological analysis confirms the diagnosis of melanoma. ② PET-CT and serum lactate dehydrogenase (LDH) can be used for auxiliary diagnosis. ③Diameter of at least one solid tumor ≥ 1cm.
5. KPS score: ≥70%.
6. Eastern Cooperative Oncology Group (ECOG) score: 0-2 grade.
7. (Within a week) Complete blood count: hemoglobin≥90g/L, leukocyte ≥ 4.0×109/L, neutrophilic granulocyte ≥ 2.0×109/L, platelet ≥ 100.0×109/L; Renal function: creatinine ≤ 180 umol/L.
8. Never accepted radiation or chemotherapy, or the interval of radiation or chemotherapy administered above 3 month.
9. Never accepted target drugs or biotherapeutics.
10. Urine pregnancy test negative (selectivity).

Exclusion Criteria:

1. Intolerable to BNCT treatment.
2. Sever coagulation disorders.
3. Poor compliance.
4. Sever complications or infection without control.
5. Pregnant woman or woman in lactation period.
6. Patients with metallic instruments (such as pacemaker, artificial limb).
7. Boron concentration in tumor tissue was \<1.5 times that in blood.
8. Age\<18.

Primary outcomes:
measure: Percentage of participants showing CR/PR to IHNI-based BNCT
timeFrame: baseline and 2 years
Secondary outcomes:
measure: Percentage of participants with treatment-related adverse events
timeFrame: 1 week, 1 month, 3 months, 6 months, 1 year and 2 years
Other outcomes:
measure: Percentage of participants of improved life quality.
timeFrame: baseline and 1 year
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Shaihong Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ke G, Sun Z, Shen F, Liu T, Li Y, Zhou Y. The study of physics and thermal characteristics for in-hospital neutron irradiator (IHNI). Appl Radiat Isot. 2009 Jul;67(7-8 Suppl):S234-7. doi: 10.1016/j.apradiso.2009.03.117. Epub 2009 Apr 9.