A Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat; Zolinza) in Combination With Bexarotene in Patients With Advanced Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 主要终点
- Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
研究概览
简要总结
This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Women or men greater than or equal to 18 years of age
- •Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with progressive, persistent, or recurrent disease
- •Failure of at least one systemic therapy, not including Bexarotene (Targretin)
- •Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement to determine your ability to perform daily activities)
排除标准
- •Patient has had investigational treatment in the preceding 30 days
- •Active hepatitis B or C, history of HIV
- •Prior treatment with any HDAC inhibitor
- •Patients must be disease free from prior malignancies for greater than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
研究组 & 干预措施
Cohort 1
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
干预措施: vorinostat (Drug)
Cohort 2
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
干预措施: vorinostat (Drug)
Cohort 2a
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
干预措施: vorinostat (Drug)
Cohort 2b
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
干预措施: vorinostat (Drug)
Cohort 6
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
干预措施: vorinostat (Drug)
Cohort 7
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)
干预措施: vorinostat (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
时间窗: Day 1 to day 28
Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.
次要结局
- Number of Participants Who Responded to Treatment(Every 28 days for up to 6 Months of Treatment)