Clinical trial NCT04534127: Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
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: 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: 2020-09-01
Enrollment: 56
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. Confirmation obtained within 6 months of planned treatment.
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds
* Brachytherapy indication validated by a multidisciplinary team
* 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.
* Measurable disease according to RECIST v1.1.
* Subjects over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
* AST and ALT ≤ 2.5 X ULN
* 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 and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor of Keratoacanthoma histology.
* Known hypersensitivity to any of the components of the treatment.
* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
* Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT
* 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.
* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
* High probability of protocol non-compliance (in opinion of investigator).
* Subjects not willing to sign an informed consent.
* 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: Change in tumor volume
timeFrame: 9-11 weeks post DaRT insertion
measure: DaRT seeds placement
timeFrame: 1 Day of 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: Progression Free Survival
timeFrame: 24 months post DaRT insertion
Other outcomes:
measure: Adverse Events
timeFrame: Up to 24 Months
Locations:
city: Jerusalem
country: Israel
facility: Sharett institute, Hadassah Medical Center - Ein-Kerem
Study officials:
affiliation: Sharett institute, Hadassah University Hospital - Ein-Kerem
name: Aron Popovtzer
role: PRINCIPAL_INVESTIGATOR
References: