Feasibility Study to Determine Effectiveness of 3.75% Topical Imiquimod Cream and Topical Vanos (Fluocinonide) Cream 0.1% in the Treatment of Early Stage Cutaneous T-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Response Rate between baseline and week 16
研究概览
简要总结
This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).
详细描述
The purpose of the study is to compare the safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage CTCL.
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
盲法说明
Open Label
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
- •Male and female subjects aged ≥18 years.
- •Willing and able to give informed consent
- •Diagnosis of Mycosis Fungoides In cases with equivocal histological features, the diagnosis may be confirmed through the use of clonal T-cell gamma gene rearrangement, as detected by PCR amplification and primer sets specific for the T-cell receptor gamma chain genes.
- •Subjects must have at least one target lesion
- •Subjects will be able to comply with the study instructions, apply the study medication as directed and attend all visits.
- •Females of child-bearing potential must have a negative urine pregnancy test before randomization and must agree to use an adequate method of contraception (abstinence, condoms, hormonal therapy, barrier methods) during the study.
- •Patients must be otherwise healthy with an ECOG Performance status of 0 or
- •The patient must not have had topical (2 weeks) or systemic therapy (4 weeks), radiotherapy (4 weeks) or phototherapy therapy (4 weeks) for Mycosis Fungoides within the stated number of weeks prior to start of treatment.
- •Eligible patients will be those who topical corticosteroid would be a preferred treatment and include patients newly diagnosed with stage IA, IB, or IIA disease, or those patients currently stable on therapy, in whom topical corticosteroids are being newly added to the regimen (i.e. recurrence or resistant lesions not currently treated with topical corticosteroids)
排除标准
- •To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- •Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- •Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.
- •Received any investigational drug or taking part in any clinical study within one month prior to this study.
- •Known reaction or allergy to test drug or excipient.
- •Presence of major medical illness or symptoms of a clinically significant illness that may influence the study.
- •Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk such as a history of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol.
- •Lesions on the genitals, axillae and face will not be selected for study treatment and evaluation.
研究组 & 干预措施
Fluocinonide (Vanos) cream 0.1%
Fluocinonide (Vanos) cream 0.1% will be applied as currently approved by the FDA for treatment of corticosteroid responsive disorders of the skin. Treatment will continue for 4 months with a follow up at 6 and 12 months.
干预措施: 0.1% Fluocinonide Cream (Drug)
3.75% Imiquimod (Zyclara) Cream
3.75% Imiquimod (Zyclara) Cream will be used as currently labeled by the FDA for treatment of actinic keratoses. Treatment will continue for 4 months with follow up at 6 and 12 months.
干预措施: 3.75% Imiquimod Cream (Drug)
结局指标
主要结局
Response Rate between baseline and week 16
时间窗: 16 weeks
Treatment phase will last 4 months with follow up at 6 and 12 months after initiation of therapy
次要结局
- Response Rate 24 and 52 weeks after baseline(Baseline to up to one year)
- Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies)(Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16))
- Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events)(From Randomization to up to 30 days after end of treatment)
研究者
Brian Poligone, MD, PhD
Scientist II
Rochester General Hospital