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Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178841
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
John Zic, Vanderbilt University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome Drug: Rosiglitazone and Bexarotene Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma
Study Start Date : June 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Intervention Details:
  • Drug: Rosiglitazone and Bexarotene
    rosiglitazone added to bexarotene capsules

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. Pruritus Score [ Time Frame: 16 weeks ]
    10-cm visual analog scale, 10= worst, 1=best

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178841

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5227
Sponsors and Collaborators
Vanderbilt University
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Principal Investigator: John A Zic, MD Vanderbilt University Medical Center

Additional Information:

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Responsible Party: John Zic, Associate Professor of Medicine/Dermatology, Vanderbilt University Identifier: NCT00178841     History of Changes
Other Study ID Numbers: 050416
First Posted: September 15, 2005    Key Record Dates
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016
Last Verified: January 2016
Keywords provided by John Zic, Vanderbilt University:
Cutaneous T-cell Lymphoma
Mycosis Fungoides
Sezary Syndrome
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents