A Study of Diffusing Alpha-Emitter Radiation Therapy (DaRT) for Skin and Soft Tissue Tumors

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Full Title

A Pilot Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin and Superficial Soft Tissue Tumors

Purpose

The usual treatment for cancerous skin and superficial soft tissue tumors is removal of the tumor by surgery and/or treatment with radiation therapy. Researchers have developed a new radiation treatment that uses the “diffusing alpha-emitter radiation therapy” (DaRT) device. This device can be placed under the skin in the tumor, and it emits (gives off) radiation. In this study, researchers want to see if DaRT is practical, safe, and effective for treating people with recurrent or persistent malignant skin or superficial soft tissue tumors.

The DaRT device is a form of “brachytherapy” (radiation sources applied directly to tumor tissue) and has seeds that give off radiation inside the tumor. Like other types of brachytherapy, DaRT delivers radiation directly to the tumor. But because it uses a type of radiation called “alpha-emitting radionucleotides,” researchers believe it may be more effective than standard brachytherapy.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a cancerous skin tumor or superficial soft tissue tumor, such as basal cell cancer, squamous cell cancer, Merkel cell cancer, melanoma, or soft tissue sarcoma such as liposarcoma, rhabdomyosarcoma, angiosarcoma, or Kaposi sarcoma. Patients with skin metastases from other solid tumors may also participate.
  • Patients’ cancers must have come back or continued to grow despite prior treatment or must be incurable with existing therapies.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Christopher Barker at 212-639-8168.

Protocol

19-367

Phase

Pilot

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator