Stereotactic Body Radiation Therapy With Immunotherapy for the Treatment of Mesothelioma

Phase 1

Active, not recruiting

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

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.

Detailed Description: PRIMARY OBJECTIVE:

I. To determine the feasibility of focal stereotactic body radiation therapy (SBRT) with immune check inhibitors (ICI) for treatment of mesothelioma.

SECONDARY OBJECTIVES:

I. To determine progression free survival in patients treated with SBRT and ICI.

II. To assess acute and late toxicities overall in patients treated with SBRT and ICI.

EXPLORATORY OBJECTIVES:

I. To determine overall survival in these patients. II. To estimate the objective response rate (ORR) using immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1 criteria.

III. To describe patterns of failure. IV. To estimate the quality of life (QOL) in these patients. V. Determine whether T-cell receptor expression changes during and after immunotherapy and SBRT, and whether these changes correlate with outcomes.

VI To evaluate potential predictive and prognostic biomarkers using various assays including flow cytometry assays, qualitative and quantitative analyses of patients' blood to explore associations with all primary and secondary endpoints.

OUTLNE:

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.

After completion of study treatment, patients are followed up every 3 months for up to 12 months.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Treatment (SBRT, immunotherapy)	Immunotherapy	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.
Treatment (SBRT, immunotherapy)	Quality-of-Life Assessment	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.
Treatment (SBRT, immunotherapy)	Stereotactic Body Radiation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From study entry to any progression or death, assessed up to 12 months	Will be estimated using the Kaplan-Meier method.
Incidence of late toxicity	Up to 90 days post-SBRT	These AEs will be shown via frequency tables and percentages. The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. Will assess and summarize all acute and late AE's, regardless of attribution.
Incidence of acute toxicity	Up to 90 days post-SBRT	These adverse events (AEs) will be shown via frequency tables and percentages. The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will assess and summarize all acute and late AE's, regardless of attribution.

Locations (1): Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States