Imaging Study for FdCyd and THU Cancer Treatment

Stopped early · Early Phase 1

Conditions studied: Head and Neck Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms

In brief

Background: \- The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the drug reacts with the cancer. This study is not a treatment study. It is open only to people who are already on the FdCyd and THU cancer treatment study. Objectives: \- To study how FdCyd affects advanced cancer cells. Eligibility: \- Participants in National Cancer Institute study 09-C-0214. Design: * Participants will have two imaging studies, one before starting FdCyd and THU treatment and one after starting treatment. * Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The doses will be followed by two imaging study scans and frequent blood samples. * This procedure will be repeated at a later date, during the FdCyd and THU treatment period. * Treatment will not be provided as part of this study. This is an imaging study protocol only....

Key facts

Study ID

NCT01479348

Run by

National Cancer Institute (NCI)

People needed

5

Starts

2011-11-01

Expected to finish

2019-01-11

Last updated by the study team

2020-06-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participants with severe claustrophobia unresponsive to oral anxiolytics
• Subjects weighing > 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry
• Known allergy to FdCyd
• The subject is unable to lie still for 75 minutes
• 5 Pregnant or lactating women. Pregnant women are excluded from this study because the effects of 18F-FdCyd in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18F-FdCyd in the mother, breastfeeding should be discontinued if the mother receives 18F-FdCyd
• Participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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