Minibeam radiation with a tungsten slit collimator for recurrent or metastatic skin and superficial soft tissue tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase I protocol delivers minibeam radiation therapy (MBRT) through a tungsten slit collimator in 2–3 fractions to patients with recurrent or metastatic skin or superficial soft tissue tumors. The primary goal is to determine the maximum tolerated dose and characterize adverse events; secondary and exploratory endpoints include film dosimetry to measure peak/valley dose differentials, local progression rates at 6 and 12 months, and immune and genomic correlative studies. Participants undergo CT simulation, serial blood draws, and punch or core biopsies before and after MBRT to study systemic and tumor immune changes and DNA repair gene alterations. Patients are followed at weeks 2, 4, and 12 and months 6, 9, and 12 for safety and local control monitoring.

Why it matters

Who can join: the full rules

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 (this does not apply to the optional Riskguard or OncoExtra samples)

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.)
* COHORT A (INTACT SKIN) ONLY: 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 B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitor, monoclonal antibodies targeting vascular endothelial growth factor (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
* 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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Scott C. Lester, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.