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Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression

Phase 0
18 Years
Not Enrolling
Thyroid Cancer

Thank you

Trial Information

Rexinoid Therapy for Poorly Differentiated Thyroid Cancer: A Pilot Clinical Trial and Correlation to Retinoid and PPARy Receptor Expression

Inclusion Criteria:

- Subject must have a histologically/cytologically confirmed diagnosis of papillary,
follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid

- 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

- Females of childbearing potential must have a negative pregnancy test prior to

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The treatment period will last up to 12 months as long as the subject is responding to the study drug, bexarotene.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Joshua Klopper, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Food and Drug Administration

Study ID:



Start Date:

November 2008

Completion Date:

February 2013

Related Keywords:

  • Thyroid Cancer
  • Not respond
  • Radioactive iodine
  • Therapy
  • Shows signs
  • Aggressive behavior
  • Thyroid Neoplasms
  • Thyroid Diseases



University of Colorado Cancer Center Denver, Colorado  80262