Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL
|Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome||Drug: Rosiglitazone and Bexarotene||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: 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|
- 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
|Study Start Date:||June 2005|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Drug: Rosiglitazone and Bexarotene
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178841
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-5227|
|Principal Investigator:||John A Zic, MD||Vanderbilt University Medical Center|