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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
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
This pilot research trial studies the response in blood cells to AMP-514, a drug shown to increase immune response (capacity to fight against infections and cancer) against cancer in patients with solid tumors undergoing radiotherapy. Measuring changes in biomarkers may help doctors decide if AMP-514 should be combined with radiotherapy and when is the best time to combine the drug with radiation.

Condition or disease Intervention/treatment
Unspecified Adult Solid Tumor, Protocol Specific Other: Cytology specimen Other: Laboratory biomarker analysis

Detailed Description:

PRIMARY OBJECTIVES:

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).

OUTLINE:

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.


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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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
Correlative studies
Other Name: Cytologic sampling

Other: Laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. 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
PBMCs


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with solid malignancies to be treated with RT
Criteria

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. Histological diagnosis of any solid malignancies and candidates to be treated with RT (with or without chemotherapy). Patients who have synchronous primary solid malignancies are eligible. When the risks associated with the diagnostic procedure are very high, due to different clinical reasons (e.g., severe chronic obstructive lung disease [COPD] when a CT-guided biopsy is associated with a very high risk of pneumothorax), and a biopsy is not feasible, then the patient may be enrolled to the study as per PI judgment.
  3. ECOG performance status score of 0-3.
  4. Life expectancy of 3 months or longer.
  5. Patients able to provide a written informed consent prior to study entry.

Exclusion Criteria:

  1. Patients with contraindication to RT.
  2. Major surgery within 1 month of starting the study treatment.
  3. Prior chemotherapy or radiotherapy for their solid malignancies.
  4. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection.
  5. Active infection with hepatitis B or hepatitis C (blood testing is not required for purpose of eligibility).
  6. Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated basal or squamous cell carcinoma of skin, superficial bladder cancer or carcinoma in situ of cervix, AJCC (version 7.0) stage 0 or I breast cancer, AJCC (version 7.0) stage I, or II prostate cancer.
  7. Patients are excluded if they have a history of autoimmune disease, as follows: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis) are excluded. Patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy.
  8. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation and in the judgment of the investigator would make the subject inappropriate for entry into this study.

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): NCT02153151


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
MedImmune LLC
Investigators
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Principal Investigator: Voichita Bar-Ad, MD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02153151     History of Changes
Other Study ID Numbers: 13D.374
2013-021 ( Other Identifier: CCRRC )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017