Stereotactic Body Radiation Therapy With Immunotherapy for the Treatment of Mesothelioma

NCT04926948 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: MC1924NCI-2021-0430219-012226
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Mesothelial Neoplasm

Outcome Measures

Primary Outcomes (1)

• Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor

  Feasibility of treating patients with SBRT and ICI will be determined by ability to treat all enrolled patients without meeting stopping rules (maintaining \<30%toxicity).

  Up to 2 years

Secondary Outcomes (3)

• Progression-free survival (PFS)

  Up to 2 years

• Incidence of acute toxicity

  Up to 90 days post-SBRT

• Incidence of late toxicity

  Up to 90 days post-SBRT

Other Outcomes (4)

• Response rate

  Up to 2 years

• Patterns of failure

  Up to 2 years

• Quality of life (QOL)

  Baseline up to 2 years

Study Arms (1)

Treatment (SBRT, immunotherapy)

EXPERIMENTAL

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.

Other: Immunotherapy; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy

Interventions

Immunotherapy OTHER

Immunotherapy

Also known as: Immunological, Immunological Therapy, Immunologically Directed Therapy

Treatment (SBRT, immunotherapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBRT, immunotherapy)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT, immunotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Histological confirmation of pleural mesothelioma
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
• Negative pregnancy test done =\< 14 days prior to registration, for women of childbearing potential only. NOTE: male/female: Must be willing to use birth control for the entire study and must agree to use one of the following birth control methods listed:
• Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
• Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
• Intrauterine device (IUD)
• Abstinence (no sex)
• Provide written informed consent
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Willing to provide blood samples for correlative research purposes
• Patient has received or is planning to receive ICI for mesothelioma
• Patient is planning to receive SBRT (stereotactic body radiation therapy) for mesothelioma

You may not qualify if:

• Any of the following:
• Pregnant women
• Nursing women

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Immunotherapy; Adjuvants, Immunologic; Radiosurgery

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William G. Breen, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 15, 2021
• Study Start: July 12, 2021
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)