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
  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

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:
Breast Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms
Urinary Bladder Neoplasms
Breast Diseases
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014