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Bexarotene

Rosiglitazone

rosiglitazone added to bexarotene capsules

Rosiglitazone and Bexarotene

John A Zic, MD

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.

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

mSWAT scoring. Range 0 to 400. Measured every 4 weeks.

FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best

10-cm visual analog scale, 10= worst, 1=best

Vanderbilt University

Associate Professor of Medicine/Dermatology

All enrolled patients received rosiglitazone in addition to oral bexarotene.

All enrolled patients received rosiglitazone in addition to oral bexarotene

Single Arm Study

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

John Zic, MD

All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.

Number of Participants With a 50% Improvement in Baseline Skin Score

Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.

Quality of Life Evaluations

Pruritus Score

Overall Study

Spots Global Cancer Trial Database for rosiglitazone and bexarotene