A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides
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
- Objective Response Rate
研究概览
简要总结
The goal of this clinical research study is to learn if a lower than standard dose of total skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The safety of this dose level will also be studied.
详细描述
Study Radiation:
During total skin electron beam therapy, radiation is given to the entire surface of the skin. This may cause the cancer cells to die.
Researchers would like to learn the level of effectiveness of this lower dose of radiation therapy because it is likely to have fewer side effects than the standard, higher dose.
Screening Period:
Signing this consent form does not mean that you will be able to take part in this study. You will have the following "screening tests" to help the doctor decide if you are eligible to take part in this study.
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
- •Biopsy-confirmed mycosis fungoides in stage IB-IIIA
- •Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids
- •18 years of age or older
- •Life expectancy greater than 6 months
- •Eastern Cooperative Oncology Group (ECOG) of </= 2
- •Adequate bone marrow function: White blood count (WBC) >/= 2000/uL; platelet count>/= 100,000/mm3; Absolute neutrophil count (ANC) >/= 1000
- •Required wash out period for prior therapies (Note: patients with progressive disease may be treated earlier than required washout period per Investigator's decision) a) Topical therapy: 2 weeks, b) Systemic biologic, monoclonal antibody or chemotherapy: 4 weeks, c) Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks, d) Other investigational therapy: 4 weeks
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study)
- •Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment
- •Prior malignancy (active within 5 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix
- •Pregnant or lactating
- •Initiation or change in dosage of topical corticosteroids within 3 weeks of study treatment (Note: topical steroid use within 3 weeks is allowed provided the strength and use has been stable for at least 1 month; 'prescription strength' topical corticosteroids cannot be started during the study)
- •Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study
结局指标
主要结局
Objective Response Rate
时间窗: Baseline and at least 2 months
Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT). Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score.
次要结局
未报告次要终点