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Imaging Study for FdCyd and THU Cancer Treatment

NCT01479348 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-06-02

Study results available
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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....

Conditions

  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Urinary Bladder Neoplasms
  • Breast Neoplasms

Interventions

DRUG

[F-18]-5-FLUORO-2'-DEOXYCYTIDINE

18FdCyd radiotracer

DRUG

Tetrahydrouridine intravenous (IV)

Total dose of THU = 350 mg/m\^2, IV

DRUG

Tetrahydrouridine (oral)

Total dose of THU is 3000 mg, oral

DIAGNOSTIC_TEST

Positron emission tomography (PET)/Computed tomography (CT)

One prior CT and 3 sequential whole body PET

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Karen A Kurdziel, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-01
Primary Completion
2017-08-04
Completion
2019-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479348 on ClinicalTrials.gov