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

This study has been completed.
Sponsor:
Collaborators:
American Cancer Society, Inc.
Eisai Inc.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00718770
First received: July 17, 2008
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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.

Condition Intervention Phase
Thyroid Cancer
 Drug: Bexarotene
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • The treatment period will last up to 12 months as long as the subject is responding to the study drug, bexarotene. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2008
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bexarotene
Open label - all patients receive intervention
 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.
Other Name: LGD-1069

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer.
  • Subjects must have evidence of follicular cell-derived thyroid cancer progression. In patients with anatomically stable disease, PET positive lesions will also be eligible given the poor prognostic risk for PET positive thyroid cancer.
  • Subjects must not be eligible for surgical resection.
  • Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Subjects must have Laboratory values that fall within certain ranges.
  • Subjects must be age 18 years or older.
  • Subjects must provide written informed consent prior to any study procedures being performed.
  • Females of Childbearing potential must have a negative pregnancy test prior to enrollment.
  • All eligible subjects must be willing to use adequate contraception throughout the duration of the study.
  • Subjects must be willing to submit a primary tumor tissue sample for immunohistochemical analysis.
  • Subjects have the option of providing one additional test tube of blood taken at baseline, 6 months and 1 year for banking of plasma for potential future studies (no genetic testing will be conducted). The current planned analysis is for the assessment of a potential peripheral marker for rexinoid responsive cancer - leukemia inhibitory factor (LIF)

Exclusion Criteria:

  • Subjects with a known history of hyperlipidemia refractory to treatment.
  • Subjects with a known history of hypertriglyceridemia refractory to treatment.
  • Subjects with leukopenia (below the reference range for the University of Colorado Hospital(UCH)laboratory.
  • Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding.
  • Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator.
  • Subjects with any prior history of malignancy with the exception of adequately treated basal cell skin cancer, in situ cervical cancer or other cancer for which the subject has been disease free for 3 years or more.
  • Subjects without radiographically assessable disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718770

Locations
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
American Cancer Society, Inc.
Eisai Inc.
Investigators
Principal Investigator: Joshua Klopper, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00718770     History of Changes
Other Study ID Numbers: 07-0727.cc
Study First Received: July 17, 2008
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Not respond
Radioactive iodine
Therapy
Shows signs
Aggressive behavior

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
 Bexarotene
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013