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Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Zic, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178841
First received: September 12, 2005
Last updated: January 20, 2016
Last verified: January 2016

September 12, 2005
January 20, 2016
June 2005
March 2007   (final data collection date for primary outcome measure)
Number of Participants With a 50% Improvement in Baseline Skin Score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
mSWAT scoring. Range 0 to 400. Measured every 4 weeks.
Skin score calculated monthly at clinic visits.
Complete list of historical versions of study NCT00178841 on ClinicalTrials.gov Archive Site
  • Quality of Life Evaluations [ Time Frame: baseline and every 4 weeks ] [ Designated as safety issue: No ]
    FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best
  • Pruritus Score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    10-cm visual analog scale, 10= worst, 1=best
The safety and tolerability of combination therapy with bexarotene and rosiglitazon assessed every two weeks via laboratory testing and every four weeks via quality of life evaluations.
Not Provided
Not Provided
 
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cutaneous T-cell Lymphoma
  • Mycosis Fungoides
  • Sezary Syndrome
Drug: Rosiglitazone and Bexarotene
rosiglitazone added to bexarotene capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
March 2007
March 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178841
050416
No
Not Provided
Not Provided
John Zic, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: John A Zic, MD Vanderbilt University
Vanderbilt University
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP