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

Conditions:Cancer, Endocrine, Thyroid Cancer
Therapuetic Areas:Endocrinology, Oncology
Age Range:Any
Start Date:November 2008
Contact:Brittany Hines

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

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.

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 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

- 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
We found this trial at
13001 E. 17th Pl.
Aurora, Colorado 80045
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
Aurora, CO
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