Clinical trial NCT04540588: Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
Official title: A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
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
Recurrent disease
Persistent lesion
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 39
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 re-treatment with 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 either recurrent or persistent disease following DaRT treatment. .

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 either recurrent or persistent disease following DaRT treatment.
* Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
* Target lesion technically amenable for full coverage with the Alpha DaRT seeds.
* Brachytherapy indication validated by a multidisciplinary team.
* 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.
* AST and ALT ≤ 2.5 X ULN
* WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
* International normalized ratio of prothrombin time ≤1.4 for patients not on Warfarin
* Creatinine ≤2.3 mg/dL.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation 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:

* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
* 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.
* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* 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.
* 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)
* 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: From conscent up to 9-11 weeks post DaRT insertion
Secondary outcomes:
measure: Change in tumor volume
timeFrame: 9-11 weeks post DaRT insertion
measure: Local control rate
timeFrame: 9-11 weeks post DaRT insertion
Other outcomes:
measure: Adverse Events
timeFrame: From conscent up to 9-11 weeks post DaRT insertion
Locations:
city: Jerusalem
country: Israel
facility: Sharett institute, Hadassah University Hospital - Ein-Kerem
Study officials:
affiliation: Sharett institute, Hadassah Medical Center - Ein-Kerem
name: Aron Popovtzer, M.D
role: PRINCIPAL_INVESTIGATOR
References: