Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
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|ClinicalTrials.gov Identifier: NCT00178841|
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome||Drug: Rosiglitazone and Bexarotene||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Drug: Rosiglitazone and Bexarotene
rosiglitazone added to bexarotene capsules
- 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.
- 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
- Pruritus Score [ Time Frame: 16 weeks ]10-cm visual analog scale, 10= worst, 1=best
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 ClinicalTrials.gov identifier (NCT number): NCT00178841
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-5227|
|Principal Investigator:||John A Zic, MD||Vanderbilt University Medical Center|