Study Stopped
Slow, insufficient accrual.
Imaging Study for FdCyd and THU Cancer Treatment
Phase 0 Trial of [F-18]-5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine
2 other identifiers
interventional
5
1 country
1
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 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....
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Nov 2011
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2019
CompletedResults Posted
Study results publicly available
May 22, 2020
CompletedJune 2, 2020
May 1, 2020
5.8 years
November 22, 2011
April 27, 2020
May 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
\[F-18\]-5-fluoro-2'-deoxycytidine (FdCyd) was administered intravenously with administration of tetrahydrouridine (THU) and the frequency and severity of adverse events was observed. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 0 is normal, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life-threatening consequences, and Grade 5 is death related to adverse event.
Within 5 days after interventions
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Radiation dosimetry was determined based on the first patients. This involved making region of interest measurements on the scan for each major organ and measuring the uptake. Using standard dosimetry software this is converted into mSv/MBq, a standard measure of dosimetry. The software is known as Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA) and is commonly used to generate this kind of data.
1 year
Secondary Outcomes (2)
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
9 minutes, 32 minutes, 56 minutes and 2 hours after injection
Number of Participants With Serious and Non-Serious Adverse Events
Date treatment consent signed to date off study, approximately 20 months and 12 days.
Study Arms (2)
1/Intravenous (IV) Tetrahydrouridine (THU)
EXPERIMENTAL\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
2/Oral Tetrahydrouridine (THU)
EXPERIMENTAL\[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
Interventions
18FdCyd radiotracer
Total dose of THU = 350 mg/m\^2, IV
Total dose of THU is 3000 mg, oral
One prior CT and 3 sequential whole body PET
Eligibility Criteria
You may qualify if:
- 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
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Carter SK. Editorial: Large-bowel cancer-The current status of treatment. J Natl Cancer Inst. 1976 Jan;56(1):3-10. doi: 10.1093/jnci/56.1.3. No abstract available.
PMID: 1255749BACKGROUNDDoroshow JH, Multhauf P, Leong L, Margolin K, Litchfield T, Akman S, Carr B, Bertrand M, Goldberg D, Blayney D, et al. Prospective randomized comparison of fluorouracil versus fluorouracil and high-dose continuous infusion leucovorin calcium for the treatment of advanced measurable colorectal cancer in patients previously unexposed to chemotherapy. J Clin Oncol. 1990 Mar;8(3):491-501. doi: 10.1200/JCO.1990.8.3.491.
PMID: 2407810BACKGROUNDHARTMANN JR, ORIGENES ML Jr, MURPHY ML, SITARZ A, ERLANDSON M. EFFECTS OF 2'-DEOXY-5-FLUOROURIDINE (NSC-27640) AND 5-FLUOROURACIL (NSC-19893) ON CHILDHOOD LEUKEMIA. Cancer Chemother Rep. 1964 Jan;34:51-4. No abstract available.
PMID: 14116219BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Karen Kurdziel
- Organization
- National Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Karen A Kurdziel, M.D.
National Cancer Institute (NCI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 22, 2011
First Posted
November 24, 2011
Study Start
November 1, 2011
Primary Completion
August 4, 2017
Study Completion
January 11, 2019
Last Updated
June 2, 2020
Results First Posted
May 22, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share