DaRT Seeds for Skin Cancer
Recruiting in Palo Alto (17 mi)
+30 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Alpha Tau Medical LTD.
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a multi-center clinical study enrolling up to 86 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy, as well as to assess the Duration of Response (DOR) 6 months from initial response. Secondary objectives are to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are undergoing systemic immunosuppressive therapy or have received certain treatments like chemotherapy, immunotherapy, or radiation therapy within 4 weeks of enrollment.
What data supports the effectiveness of the treatment DaRT224 for skin cancer?
Research shows that DaRT224, a treatment using alpha particles, effectively controls tumors in skin and head and neck cancers, with 100% response rates in some cases. It also enhances the body's immune response against tumors, making it a promising option for difficult-to-treat cancers.
12345Is DaRT therapy safe for treating skin cancer?
DaRT therapy has been studied for safety in treating skin and head and neck cancers, showing it is feasible and generally safe. However, there is a potential risk to organs like the kidneys and red bone marrow due to radiation, but these risks are managed to stay within safe limits.
23456How is the DaRT224 treatment different from other skin cancer treatments?
DaRT224 is unique because it uses alpha particles, which are a type of radiation, to target and kill cancer cells directly within the tumor. This treatment involves placing a small source of radiation inside the tumor, allowing the alpha particles to spread and create a high-dose area that can effectively destroy cancer cells, offering a new option for patients with limited treatment choices.
34567Eligibility Criteria
This trial is for adults over 18 with recurrent skin cancer (cutaneous Squamous Cell Carcinoma) that's not treatable by surgery or standard radiation. Participants must have tried at least one standard treatment, be in fairly good health with a life expectancy of more than a year, and able to undergo CT scans. They should also agree to use effective birth control methods.Inclusion Criteria
My tumor is 7 cm or smaller in its largest size.
I have only one cancerous lesion.
My cancer can be fully treated with DaRT seeds without affecting vital organs.
I can take care of myself but might not be able to do heavy physical work.
I am willing and able to sign the Informed Consent form.
My kidney function is within the normal range.
Exclusion Criteria
My cancer has not spread to distant organs or lymph nodes.
My cancer has spread deeply or to nerves.
I have skin cancer that has not been treated and needs surgery or radiation.
My cancer is located in the mucosal, vulvar, anal, or penile areas.
My cancer cannot be fully treated with DaRT seeds.
DaRT seeds cannot be placed in my tumor due to its location near bones or vital organs.
I am currently receiving or have received chemotherapy or biological therapy for cancer.
I have not received any live vaccines in the last 30 days.
My largest tumor is bigger than 7 cm.
My tumor is identified as keratoacanthoma type.
I do not have serious heart conditions like severe heart failure or recent heart attack.
Participant Groups
The study tests DaRT seeds - a type of internal radiation therapy - on up to 86 patients across multiple centers. It aims to see how well the treatment works (measured by tumor response), how long it lasts, its safety profile, and effects on survival rates and quality of life.
1Treatment groups
Experimental Treatment
Group I: DaRT seedsExperimental Treatment1 Intervention
DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CenterUniondale, NY
City of HopeLos Angeles, CA
University Cancer & Diagnostic CenterHouston, TX
UCLALos Angeles, CA
More Trial Locations
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Who is running the clinical trial?
Alpha Tau Medical LTD.Lead Sponsor
References
Diffusing Alpha-Emitters Radiation Therapy Promotes a Proimmunogenic Tumor Microenvironment and Synergizes With Programmed Cell Death Protein 1 Blockade. [2023]Diffusing alpha-emitters Radiation Therapy (DaRT) releases alpha-emitting atoms into the tumor microenvironment. The treatment effectively ablates human and mice xenografts and shows 100% response rates in skin or head and neck squamous cell carcinoma patients. DaRT induces specific and systemic antitumor immune activation and synergizes with immune stimulation and modulation in mice. Here, the transcriptional profile activated by DaRT, and its potential to enhance responsiveness to immune checkpoint inhibition by programmed cell death protein 1 (PD-1) blockade were studied.
The treatment of solid tumors by alpha emitters released from (224)Ra-loaded sources-internal dosimetry analysis. [2013]Diffusing alpha-emitters radiation therapy (DART) is a proposed new form of brachytherapy, allowing the treatment of solid tumors by alpha particles. DART utilizes implantable sources carrying small activities of radium-224, which continually release into the tumor radon-220, polonium-216 and lead-212 atoms, while radium-224 itself remains fixed to the source. The released atoms disperse inside the tumor by diffusive and convective processes, creating, through their alpha emissions, a high-dose region measuring several mm in diameter about each source. The efficacy of DART has been demonstrated in preclinical studies on mice-borne squamous cell carcinoma and lung tumors and the method is now being developed toward clinical trials. This work studies DART safety with respect to the dose delivered to distant organs as a result of lead-212 leakage from the tumor through the blood, relying on a biokinetic calculation coupled to internal dose assessments. It is found that the dose-limiting organs are the kidneys and red bone marrow. Assuming a typical source spacing of approximately 5 mm and a typical radium-224 activity density of 0.4-0.8 MBq g(-1) of tumor tissue, it is predicted that tumors weighing up to several hundred grams may be treated without reaching the tolerance dose in any organ.
Initial Safety and Tumor Control Results From a "First-in-Human" Multicenter Prospective Trial Evaluating a Novel Alpha-Emitting Radionuclide for the Treatment of Locally Advanced Recurrent Squamous Cell Carcinomas of the Skin and Head and Neck. [2020]Our purpose was to report the feasibility and safety of diffusing alpha-emitter radiation therapy (DaRT), which entails the interstitial implantation of a novel alpha-emitting brachytherapy source, for the treatment of locally advanced and recurrent squamous cancers of the skin and head and neck.
Feasibility and Safety of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or Unresectable Skin Cancers. [2023]Patients with recurrent or unresectable skin cancers have limited treatment options. Diffusing alpha-emitter radiation therapy (DaRT), a novel solid tumor management strategy using alpha-particle interstitial brachytherapy, may address this challenge.
Local control of lung derived tumors by diffusing alpha-emitting atoms released from intratumoral wires loaded with radium-224. [2013]Diffusing alpha-emitters radiation therapy (DART) is a new form of brachytherapy enabling the treatment of solid tumors with alpha radiation. The present study examines the antitumoral effects resulting from the release of alpha emitting radioisotopes into solid lung carcinoma (LL2, A427, and NCI-H520).
The low-LET radiation contribution to the tumor dose in diffusing alpha-emitters radiation therapy. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Diffusing alpha-emitters Radiation Therapy ("Alpha DaRT") is a new technique that enables the use of alpha particles for the treatment of solid tumors. Alpha DaRT employs interstitial sources carrying a few μCi of 224 Ra below their surface, designed to release a chain of short-lived atoms (progeny of 224 Ra) which emit alpha particles, along with beta, Auger, and conversion electrons, x- and gamma rays. These atoms diffuse around the source and create-primarily through their alpha decays-a lethal high-dose region measuring a few millimeters in diameter.
A finite element method for modeling diffusion of alpha-emitting particles in tissue. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Diffusing alpha-emitters Radiation Therapy ("DaRT") is a promising new modality for the treatment of solid tumors. Interstitial sources containing 224 Ra are inserted into the tumor, producing alpha particles via the decay of 224 Ra and its daughters. The alpha particles are able to produce a "kill region" of several mm due to the diffusion of the alpha-emitting atoms. The Diffusion-Leakage (D-L) model has been proposed to describe the movement of the alpha-emitters used in DaRT in tumor tissue.