CompletedNot Applicable

Measuring Biomarker Response to AMP-514 in Blood Samples From Patients With Solid Tumors Undergoing Radiotherapy

United States21 participantsStarted 2013-11-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients 18 years of age or older
. 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.
. ECOG performance status score of 0-3.
. Life expectancy of 3 months or longer.
. Patients able to provide a written informed consent prior to study entry.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in peripheral blood T cell proliferation (stimulation) and cytokine production in vitro

Timeframe: Baseline to up to 1 month after the end of RT

Trial details

NCT IDNCT02153151

SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-02-23

View on ClinicalTrials.gov More Unspecified Adult Solid Tumor, Protocol Specific trials