Imaging Study for FdCyd and THU Cancer Treatment
- The drugs FdCyd (also called 5-fluoro-2'-deoxcytidine) 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.
- To study how FdCyd affects advanced cancer cells.
- Participants in National Cancer Institute study 09-C-0214.
- 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....
Head and Neck Neoplasms
Urinary Bladder Neoplasms
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Phase 0 Trial of [F-18]-5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine|
- Safety of [F-18]-5-fluoro-2'-deoxycytidine (FdCyd) administered intravenously with administration of tetrahydrouridine (THU) [ Time Frame: Within 5 days after enrollment ] [ Designated as safety issue: Yes ]
- Estimate the radiation dosimetry of [F-18]-FdCyd in humans [ Time Frame: Within 5 days after enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479348
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Karen A Kurdziel, M.D.||National Cancer Institute (NCI)|