Retreatment with a new type of radiation therapy for skin and oral cancers
A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
This study is testing a new type of radiation therapy that puts tiny radioactive seeds directly into skin and mouth cancers to see if it can shrink tumors while keeping healthy tissue safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alpha Tau Medical LTD. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT04540588 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a novel treatment using intratumoral diffusing alpha radiation emitters (DaRT) for patients with recurrent or persistent skin and mucosal cancers. The study involves inserting radioactive seeds directly into the tumor to deliver localized radiation therapy, which aims to reduce tumor size while minimizing exposure to surrounding healthy tissue. Participants will be monitored for tumor response and any adverse effects over a period of 70 days following treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed recurrent or persistent tumors that are 5 cm or smaller and suitable for treatment with alpha radiation.
Not a fit: Patients with tumors larger than 5 cm or those who do not have histopathological confirmation of disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and targeted approach to managing difficult-to-treat skin and mucosal cancers.
How similar studies have performed: While this approach is innovative, similar studies using localized radiation therapies have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jerusalem
- Sharett institute, Hadassah University Hospital - Ein-Kerem — Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Aron Popovtzer, M.D — Sharett institute, Hadassah Medical Center - Ein-Kerem
- Study coordinator: Adi Cohen
- Email: adic@alphatau.com
- Phone: +972-2-3737-212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.