Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Skin score calculated monthly at clinic visits.
John A Zic, MD
United States: Food and Drug Administration
|Vanderbilt University Medical Center||Nashville, Tennessee 37232-2516|