Measuring Biomarker Response to AMP-514 in Blood Samples From Patients With Solid Tumors Undergoing Radiotherapy
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|ClinicalTrials.gov Identifier: NCT02153151|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : September 6, 2017
|Condition or disease||Intervention/treatment|
|Unspecified Adult Solid Tumor, Protocol Specific||Other: Cytology specimen Other: Laboratory biomarker analysis|
I. To evaluate the in-vitro effect of AMP-514, a programmed cell death 1 (PD-1) inhibitor, on peripheral blood T cell proliferation and cytokine production from patients with solid malignancies, treated with radiotherapy (RT).
Patients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT.
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||A Pilot Study to Evaluate the In-vitro Effect of AMP-514, a PD-1 Inhibitor, on Peripheral Blood T Cell Proliferation and Cytokine Production From Patients With Solid Malignancies Treated With Radiotherapy (RT)|
|Actual Study Start Date :||November 11, 2013|
|Actual Primary Completion Date :||February 23, 2016|
|Actual Study Completion Date :||July 14, 2016|
In vitro effect of AMP-514
Patients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT
Other: Cytology specimen
Other Name: Cytologic sampling
Other: Laboratory biomarker analysis
- Change in peripheral blood T cell proliferation (stimulation) and cytokine production in vitro [ Time Frame: Baseline to up to 1 month after the end of RT ]Mixed effects linear regression used to model each marker. Markers measured under treated and control conditions at 4 time points. Saturated fixed effects model including fixed effects for treatment condition, evaluation time & condition by time interaction used. Repeated measures covariance structure that accounts for correlation between treated & control samples at each time & correlation among repeated samples from the 4 measurement periods assumed. Overall effect of treatment as well as time-specific estimates of treatment effect estimated along with appropriate 95% confidence intervals.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153151
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Voichita Bar-Ad, MD||Thomas Jefferson University|