Clinical trial NCT03737734: Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Cancer
Mucosal Neoplasm of Oral Cavity
Soft Tissue Neoplasm
Keywords: Squamous Cell Carcinoma
SCC
Skin Cancer
Skin metastasis
HNSCC
Carcinoma, Squamous
CMN
Basal cell carcinoma
Superficial sarcoma
Kaposi sarcoma
Alpha radiation
Cutaneous lesion
Tongue cancer
Lip cancer
Brachytherapy
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2018-11-09
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: A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Detailed description: This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility criteria: Inclusion Criteria:

* Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* International normalized ratio of prothrombin time ≤1.8.
* Creatinine ≤1.9 mg/dL.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor of Keratoacanthoma histology.
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* High probability of protocol non-compliance (in opinion of investigator)
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Tumor response to DaRT
timeFrame: 9-11 weeks post DaRT insertion
measure: Adverse Events
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Reduction in tumor volume
timeFrame: 9-11 weeks post DaRT insertion
measure: DaRT seeds placement
timeFrame: Day of insertion procedure
measure: Change in quality of life
timeFrame: Day 15, Day 30, Day 70, Day 180 post DaRT insertion
measure: Change in quality of life
timeFrame: Day 30, Day 70, Day 180 post DaRT insertion
measure: Adverse Events
timeFrame: Up to 24 Months
measure: Progression Free Survival
timeFrame: 24 months post DaRT insertion
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Davidof Cancer Institution at the Rabin Medical Center Israel
Study officials:
affiliation: Davidof Cancer Institution at Rabin Medical Center Israel
name: Noga Kurman, MD
role: PRINCIPAL_INVESTIGATOR
References: