Overview

About this study

This is a dose-finding trial with the aim of deriving the MTD of MBRT in patients with recurrent or metastatic skin or soft tissue tumors and indications for palliative radiotherapy. We will also examine the ability to maintain a distinct differential between peak and valley doses using film dosimetry and explore adverse event profile and local disease control. Treatment will consist of MBRT at one dose level (valley dose 3 Gy x 2 fractions, 4 Gy x 2 fractions, 5 Gy x 2 fractions, 3 Gy x 3 fractions, 4 Gy x 3 fractions, 5 Gy x 3 fractions). The DLT evaluation period is 28 days. Patients will be followed for adverse events for one year. Blood and tumor samples will be collected before and after MBRT for correlative science. Two separate cohorts of patients will be enrolled, one with intact skin and one with disrupted skin with a maximum of 30 patients enrolled in each cohort.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age ≥ 18 years.
  • Histologically confirmed malignancy.
  • Primary, recurrent, or metastatic skin or superficial soft tissue tumor amenable to palliative orthovoltage radiotherapy.
  • Anticipated life expectancy ≥ 30 days and anticipated capacity for follow up for ≥ 30 days.
  • Negative pregnancy test done ≤ 28 days prior to registration, for biological women of childbearing potential only.
  • Willing to provide written informed consent.
  • Willing to allow baseline and follow up photograph acquisition for response and toxicity assessment.
  • Willing and able to return to enrolling institution for follow-up during the Active Monitoring Phase of the study.
  • Willing to provide blood and tissue samples for correlative research purposes (see Section 6.2).

Exclusion Criteria

  • Hematologic, germ cell, or any other tumor that the investigational team would deem to have a high likelihood of clinical complete response with standard palliative radiotherapy (8 Gy in 1, 30 Gy in 10, etc.).
  • Prior radiotherapy targeting the lesion presenting for treatment or prior adjacent radiotherapy if > 10 Gy overlaps with a portion of the planned target.
  • Treatment with a BRAF inhibitor, monoclonal antibodies targeting VEGF (bevacizumab or ramucirumab) or small molecule inhibitors inhibiting VEGF within the last 2 weeks or planned treatment with BRAF inhibitor within 4 weeks after radiation.
  • Planned treatment with cytotoxic chemotherapy within the 4 weeks after MBRT (the DLT period).
  • Treatment with an investigational drug therapy within 2 weeks prior to or 4 weeks (the DLT monitoring period) after MBRT
  • Any tumor with direct extension into the spine such that targeting the spine/spinal cord could not be avoided.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Scott Lester, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20584629

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