Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants With a 50% Improvement in Baseline Skin Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Participants With a 50% Improvement in Baseline Skin Score
时间窗: 16 weeks
mSWAT scoring. Range 0 to 400. Measured every 4 weeks.
次要结局
- Pruritus Score(16 weeks)
- Quality of Life Evaluations(baseline and every 4 weeks)
研究者
John Zic
Associate Professor of Medicine/Dermatology
Vanderbilt University