SBRT + Immunotherapy for Mesothelioma

Recruiting in Palo Alto (17 mi)

Overseen byWilliam G. Breen, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the effect of stereotactic body radiation therapy and immunotherapy in treating patients with mesothelioma. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving stereotactic body radiation therapy and immunotherapy may improve the tumors response to the treatment and decrease side-effects.

Eligibility Criteria

Adults with confirmed pleural mesothelioma, who can undergo stereotactic body radiation therapy (SBRT) and immunotherapy. Participants must be able to give consent, follow up at the institution, have an ECOG performance status of ≤2, not be pregnant or nursing, and agree to use effective birth control.

Inclusion Criteria

I am planning to undergo SBRT for mesothelioma.

Must be willing to use birth control for the entire study and must agree to use one of the following birth control methods: Hormonal methods, barrier methods used with a spermicide, intrauterine device (IUD), abstinence

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

+8 more

Exclusion Criteria

I am currently breastfeeding.

Pregnant women

Participant Groups

The trial is testing how well patients with mesothelioma respond to a combination of high-precision radiation therapy called SBRT and immune-boosting treatments known as immunotherapy. The goal is to see if this combo improves tumor response while minimizing side effects.

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT, immunotherapy)Experimental Treatment3 Interventions

Patients undergo 3-5 daily fractions of SBRT in the absence of disease progression or unacceptable toxicity. Patients also receive immunotherapy at the discretion of the treating medical oncologist.

Immunotherapy is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Various Immunotherapies for: