Imaging Study for FdCyd and THU Cancer Treatment
This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01479348
First received: November 22, 2011
Last updated: June 25, 2014
Last verified: May 2014
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Purpose
Background:
- 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.
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....
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Neoplasms Lung Neoplasms Urinary Bladder Neoplasms Breast Neoplasms |
Drug: [F-18]-5-FLUORO-2'-DEOXYCYTIDINE |
Phase 0 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- 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 ]
| Enrollment: | 5 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
[F-18]-5-fluoro-2'-deoxycytidine
|
Drug: [F-18]-5-FLUORO-2'-DEOXYCYTIDINE
N/A
|
|
Experimental: B
[F-18]-5-fluoro-2'-deoxycytidine
|
Drug: [F-18]-5-FLUORO-2'-DEOXYCYTIDINE
N/A
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- INCLUSION CRITERIA:
- Enrolled in the NIH Phase II Clinical protocol evaluating FdCyd with THU (09-C-0214) with target lesion measured as greater than or equal to 10mm with spiral 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 18FFdCyd in the mother, breastfeeding should be discontinued if the mother receives 18FFdCyd
- Participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479348
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479348
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Karen A Kurdziel, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT01479348 History of Changes |
| Other Study ID Numbers: | 120014, 12-C-0014 |
| Study First Received: | November 22, 2011 |
| Last Updated: | June 25, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Imaging Radiopharmaceutical Safety |
Dosimetry Drug Distribution Cancer |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms Urinary Bladder Neoplasms Neoplasms by Site |
Urinary Bladder Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms |
ClinicalTrials.gov processed this record on February 27, 2015