A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 28
- 主要终点
- Overall response rate (complete clinical response [CCR) and partial response [PR])
研究概览
简要总结
RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.
PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.
详细描述
OBJECTIVES:
- Determine if ultraviolet A light therapy with methoxsalen (PUVA) with or without bexarotene yields a significantly higher overall response rate in patients with mycosis fungoides.
- Compare the overall response rate (CCR and partial response) in patients treated with these regimens.
- Compare the duration of CCR and time to relapse of patients treated with these regimens.
- Compare the number of PUVA sessions necessary to achieve a CCR in these patients.
- Determine the percentage of dropouts by patients treated with these regimens.
- Determine the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and stage of disease (IB vs IIA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy. PUVA is given 3 times per week.
- Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms, treatment repeats for up to 16 weeks in the absence of complete clinical response, disease progression, or unacceptable toxicity.
Patients are followed every 8 weeks until the first documented progression or relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bexarotene and PUVA
干预措施: bexarotene (Drug)
Bexarotene and PUVA
干预措施: methoxypsoralen (Drug)
Bexarotene and PUVA
干预措施: UV light therapy (Procedure)
PUVA
干预措施: methoxypsoralen (Drug)
PUVA
干预措施: UV light therapy (Procedure)
结局指标
主要结局
Overall response rate (complete clinical response [CCR) and partial response [PR])
时间窗: 35 months after first patient in
次要结局
- Number of PUVA sessions necessary to achieve a CCR(35 months after first patient in)
- Cumulative dose of UVA required to achieve CCR(35 months after first patient in)
- Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression(35 months after first patient in)
- Time to relapse(35 months after first patient in)
- Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks(35 months after first patient in)
- Percentage of dropouts as measured by the percentage of cases not completing treatment due to toxicity at the completion of treatment(35 months after first patient in)