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

NCT00718770 | Completed Early Phase 1 Results DMC

• 1 other identifier: 07-0727.cc
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Thyroid Cancer

Keywords

Not respond; Radioactive iodine; Therapy; Shows signs; Aggressive behavior

Outcome Measures

Primary Outcomes (1)

• Change in Tumor Size

  To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria

  1 year

Study Arms (1)

Bexarotene

EXPERIMENTAL

Open label - all patients receive intervention

Drug: Bexarotene

Interventions

Bexarotene DRUG

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

Also known as: LGD-1069

Bexarotene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Cancer Society, Inc.: collaborator
• Eisai Inc.: collaborator

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Aggression

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Small numbers of participants with higher than expected numbers of patients not eligible and who could not complete trial due to lack of efficacy or drug side effects

Results Point of Contact

• Title: Joshua Klopper, MD
• Organization: University of Colorado School of Medicine

joshua.klopper@ucdenver.edu

303-724-3921

Study Officials

• Joshua Klopper, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 17, 2014
• Results First Posted: January 17, 2014

Record last verified: 2013-12

Locations

US (1)