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Stereotactic Body Radiation Therapy With Immunotherapy for the Treatment of Mesothelioma

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ClinicalTrials.gov Identifier: NCT04926948
Recruitment Status : Not yet recruiting
First Posted : June 15, 2021
Last Update Posted : August 18, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Pleural Mesothelioma Other: Immunotherapy Other: Quality-of-Life Assessment Radiation: Stereotactic Body Radiation Therapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SBRT With Immunotherapy for Mesothelioma
Estimated Study Start Date : October 24, 2021
Estimated Primary Completion Date : May 25, 2025
Estimated Study Completion Date : May 25, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: Treatment (SBRT, 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.
Other: Immunotherapy
Immunotherapy
Other Names:
  • Immunological
  • Immunological Therapy
  • Immunologically Directed Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Feasibility of treatment of patients with stereotactic body radiation therapy (SBRT) without meeting stopping rules [ Time Frame: Up to 12 months ]
    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.

  2. Feasibility of treatment of patients with immune checkpoint inhibitor (ICI) without meeting stopping rules [ Time Frame: Up to 12 months ]
    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 :
  1. Progression-free survival (PFS) [ Time Frame: From study entry to any progression or death, assessed up to 12 months ]
    Will be estimated using the Kaplan-Meier method.

  2. Incidence of acute toxicity [ Time Frame: 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.

  3. Incidence of late toxicity [ Time Frame: 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.


Other Outcome Measures:
  1. Overall survival (OS) [ Time Frame: From study entry to death from any cause, assessed up to 12 months ]
    Will be estimated using the Kaplan-Meier method.

  2. Response rate [ Time Frame: Up to 12 months ]
    The confirmed response rate (by Response Evaluation Criteria in Solid Tumors) will be assessed. The confirmed response rate frequency of responses will be calculated.

  3. Response rate [ Time Frame: Up to 12 months ]
    The confirmed response rate (by Response Evaluation Criteria in Solid Tumors) will be assessed. The confirmed response rate percentage of responses will be calculated.

  4. Patterns of failure [ Time Frame: Up to 12 months ]
    Will be described descriptively as well using standard summary statistics (percentages).

  5. Quality of life (QOL) questionnaire [ Time Frame: Baseline up to 12 months ]
    Will be assessed descriptively in these patients. Standard paired tests (paired t-test or the non-parametric equivalent) will be used to test for significance in QOL. Graphical and statistical methods will be used to summarize this data descriptively.

  6. Correlation of T-cell receptor expression changes with outcomes [ Time Frame: Baseline up to 12 months ]
    Will correlate changes with outcomes (PFS, OS, response, etc.). Potential predictive and prognostic biomarkers using various assays including flow cytometry assays, quality and quantitative analysis of patients' blood to explore associations with all primary and secondary endpoints will also be evaluated. Due to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (PFS, OS, response, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For biomarker data used to predict binary outcomes (i.e. response versus no response), will use logistic regression models.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926948


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: William G. Breen, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William G Breen Mayo Clinic in Rochester
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04926948    
Other Study ID Numbers: MC1924
NCI-2021-04302 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1924 ( Other Identifier: Mayo Clinic in Rochester )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases