Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

January 20, 2016 updated by: John Zic, Vanderbilt University

Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma

The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment options for CTCL include both skin-directed and systemic therapies. Topical treatments are effective for early-stage disease that is localized to the skin. However, disease involving the lymph nodes or visceral sites can be palliated but rarely cured, even with the most aggressive regimens of systemic chemotherapy. Unfortunately, current treatment options at this stage only provide a short term response. Thus, it is important that additional therapies are investigated to manage this malignancy.

Bexarotene has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL).Bexarotene binds the RXR(Retinoid X Receptor)inside the cell, a receptor that forms heterodimers with a multitude of other nuclear receptors. One of these is the PPARγ (Peroxisome Proliferator Activator Receptor Gamma), a nuclear receptor that binds Rosiglitazone.Rosiglitazone is an FDA approved antidiabetic agent of the Thiazolidinedione class. Rosiglitazone increases insulin sensitivity and is useful in the treatment of type 2 diabetes. In vitro data suggest that rosiglitazone and bexarotene may act synergistically to induce apoptosis in cell lines derived from patients with cutaneous T cell lymphoma (CTCL). This pilot study will investigate this possible synergism in a small cohort of patients with stable or progressive CTCL already being treated with bexarotene.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-5227
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with biopsy proven persistent or recurrent cutaneous cell lymphoma (CTCL) Stage IA-IVA
  • Patients with a pathologic proven diagnosis of CTCL that is documented in the patient history.
  • Patient has preserved organ function.
  • Patient has an ECOG performance status between 0 - 2.
  • Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
  • Patients over the age of 18 who are willing and able to provide Informed Consent
  • The patient has been taking Targretin capsules for at least the last 4 months and the dose has remained relatively stable.
  • The patient has had stable or progressive disease over the past 4 months.
  • Patient has adequate laboratory parameters for liver and kidney function.

Exclusion Criteria:

  • Patients with CD30+ Anaplastic Large Cell Lymphoma
  • Patients with pathology consistent with peripheral T-cell lymphoma.
  • Patients with Stage IVB (visceral involvement with CTCL).
  • Patients with history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
  • Patients with a diagnosis of congestive heart failure.
  • Patients exhibiting significant edema or unstable cardiovascular disease.
  • Patients with a fasting triglyceride level greater then 500mg/dl.
  • Patients that have started any new treatment for CTCL in the past 4 months.
  • Pregnant women will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a 50% Improvement in Baseline Skin Score
Time Frame: 16 weeks
mSWAT scoring. Range 0 to 400. Measured every 4 weeks.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Evaluations
Time Frame: baseline and every 4 weeks
FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best
baseline and every 4 weeks
Pruritus Score
Time Frame: 16 weeks
10-cm visual analog scale, 10= worst, 1=best
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: John A Zic, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 050416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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