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A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression

NCT00718770 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-01-17

Study results available
· View outcomes & findings →

Summary

This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior.

Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in the treatment of thyroid cancer.

The purpose of this research study is to test how well the study drug works in humans. The study doctors want to know if:

1. The subjects thyroid cancer gets smaller while you are taking the study drug.
2. The subjects thyroid cancer takes up radioactive iodine better after treatment with the study drug than before treatment.

Conditions

Interventions

DRUG

Bexarotene

Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • Eisai Inc.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Joshua Klopper, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2013-01-31
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00718770 on ClinicalTrials.gov