Status:
TERMINATED
Imaging Study for FdCyd and THU Cancer Treatment
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Head and Neck Neoplasms
Lung Neoplasms
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
BACKGROUND: \- In pre-clinical models, 5-fluoro-2-deoxycytidine (FdCyd), administered along with tetrahydrouridine (THU; an inhibitor of cytidine/deoxycytidine deaminase), has shown superior anti-tu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Enrolled in the National Institutes of Health (NIH) Phase II Clinical protocol evaluating 5-fluro-2'-deoxycytidine (FdCyd) with Tetrahydrouridine (THU) (09-C-0214) with target lesion measured as greater than or equal to 10mm with spiral computed tomography (CT) scan.
- Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
- For females: Negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01479348
Start Date
November 1 2011
End Date
January 11 2019
Last Update
June 2 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892