Description:
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.
Title
- Brief Title: Stereotactic Body Radiation Therapy With Immunotherapy for the Treatment of Mesothelioma
- Official Title: SBRT With Immunotherapy for Mesothelioma
Clinical Trial IDs
- ORG STUDY ID:
MC1924
- SECONDARY ID:
NCI-2021-04302
- SECONDARY ID:
MC1924
- SECONDARY ID:
P30CA015083
- NCT ID:
NCT04926948
Conditions
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
Eligibility Criteria
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:
- Any of the following:
- Pregnant women
- Nursing women
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Feasibility of treatment of patients with stereotactic body radiation therapy (SBRT) without meeting stopping rules |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | treatment will be considered feasible if the stopping rules are not met. The stopping rule will be met if either A) 3 or more of the first 10 patients (or 30 percent or more of all patients after 10 are accrued) experience a Grade 4 AE, or B) 2 or more experience a Grade 5 AE at any time. |
Secondary Outcome Measures
| Measure: | Progression-free survival (PFS) |
| Time Frame: | From study entry to any progression or death, assessed up to 12 months |
| Safety Issue: | |
| Description: | Will be estimated using the Kaplan-Meier method. |
| Measure: | Incidence of acute toxicity |
| Time Frame: | Up to 90 days post-SBRT |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Incidence of late toxicity |
| Time Frame: | Up to 90 days post-SBRT |
| Safety Issue: | |
| Description: | 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. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | Mayo Clinic |
Last Updated
August 18, 2021
