IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
This phase II trial studies how well low dose total skin electron beam radiation therapy and mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total skin electron beam radiation therapy uses high energy x-rays directed at the entire surface of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may help patients in remission of disease, reduction in disease staging, and enhanced quality of life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel may work better in treating patients with mycosis fungoides.
详细描述
PRIMARY OBJECTIVES:
I. To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance mechlorethamine hydrochloride gel (Valchlor) regimen.
SECONDARY OBJECTIVES:
I. To assess the response rate (complete response [CR] and partial response [PR]) of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.
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
- •Documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous T-cell lymphoma
- •Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study
- •Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator
- •Mycosis fungoides patients that have stage T2-4 N0-1 M0B0 disease
- •Availability of subject to be observed for up to 18 months post-screening evaluation
- •Life expectancy greater than 6 months
排除标准
- •Pregnant or breast-feeding females
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
- •Patients diagnosed with Sezary syndrome; Sezary syndrome is equivalent to mycosis fungoides that develops to stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT
- •Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment
- •Minimum 3 weeks since prior systematic treatment or phototherapy
- •Exclusion of people that do not understand the risks, such as decisionally-impaired individuals, prisoners, and vulnerable populations
研究组 & 干预措施
low dose TSEBT, mechlorethamine hydrochloride gel
Patients undergo low dose TSEBT for 2 weeks. After 30 days of observation, patients receive mechlorethamine hydrochloride gel topically daily at week 7 and then once weekly up to week 54.
干预措施: Mechlorethamine Hydrochloride Gel (Drug)
low dose TSEBT, mechlorethamine hydrochloride gel
Patients undergo low dose TSEBT for 2 weeks. After 30 days of observation, patients receive mechlorethamine hydrochloride gel topically daily at week 7 and then once weekly up to week 54.
干预措施: Total Skin Electron Beam Radiation Therapy (Procedure)
结局指标
主要结局
Time to progression
时间窗: Up to week 54
Will be evaluated using the Kaplan-Meier estimator of the survival curves.
次要结局
未报告次要终点