ACTRN12615001088538招募中2 期
The effect of topical imiquimod or diphenylcyclopropenone on complete clinical response in patients with cutaneous in-transit melanoma metastases - A Phase II Single Centre Prospective Randomised Pilot Study.
Professor B Mark Smithers0 个研究点目标入组 30 人开始时间: 2015年10月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Men or women aged 18 years or older.
- •2. Willing and able to comply with study requirements.
- •3. Capable of providing valid (written and informed) consent.
- •4. Histologically or cytologically proven in-transit melanoma metastases.
- •5. Measurable disease between 2-15mm in diameter that can be accurately assessed by ruler/calliper.
- •6. Between 5 to 20 in-transit melanoma lesions.
- •7. Lesions present in anatomical locations amenable to imiquimod or DPCP treatment.
- •8. Cutaneous (superficial) macular, papular or small nodular in-transit melanoma deposits.
- •9. Considered un-suitable for surgery by the treating surgeon due to anatomical location or prohibitive disease factors or co-morbidities, previous treatment failure or patient refusal.
- •10. 12 weeks minimum duration between completing comparative treatments (ILI or PV-10) to prevent potentially confounding effects (treatment responses).
- •11. Patients must have, in the opinion of the investigator, adequate renal, haematopoietic and hepatic function, with no clinically significant impairment or uncontrolled haematological, hepatic or renal disease.
排除标准
- •1. Considered eligible for concurrent treatment with systemic chemo- or immunotherapies.
- •2. Subjects who have received chemotherapy or other systemic cancer therapy within 4 weeks of study.
- •3. Subjects who have received local treatment (e.g. surgery, cryotherapy, radiofrequency ablation) to the treatment area within four weeks of study treatment - to prevent potentially confounding effects (treatment responses/immunosuppression).
- •4. Life expectancy of less than 6 months or ECOG performance status equal or greater than 3.
- •5. Medical or psychiatric condition that compromises the patient’s ability to complete the treatment or follow-up assessments as per the protocol.
- •6. Unable or unwilling to provide fully informed consent and participate including patients with intellectual or mental impairment.
- •7. Patients who are pregnant or lactating. Women of child bearing potential must have a confirmed negative urine pregnancy test at study entry.
- •8. Known history of immumodeficiency including HIV, uncontrolled central nervous system metastases, concomitant systemic corticosteroid therapy, previous organ transplant.
- •9. Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological) illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of study results.
- •10. Previous severe adverse or allergic reaction to either treatment agent.
- •11. Patients unable or unwilling to comply with home application of treatment and the investigational nature of the study.
研究者
相似试验
尚未招募
3 期
The effect of topical Imiquimod5% in treatment of high-grade cervical neoplasias (CIN2,3)The recovery rate of high-grade cervical neoplasias.IRCT20230811059116N1Iran University of Medical Sciences80
进行中（未招募）
1 期
Topical Imiquimod in Treating Patients with Persistent HPV-Infection after Surgical or Radiation Treatment of Cervical Cancer - TACTIQ (Treatment after Cervical Cancer with topical Imiquimod)-trialEUCTR2010-019657-18-ATMedizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Gynäkologie und Gyn.Onkologie
终止
3 期
Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial NeoplasiaCervical Intraepithelial NeoplasiaNCT01283763Medical University of Vienna95
进行中（未招募）
1 期
Effect of topical imiquimod on lentigo maligna. - Effect of topical imiquimod on lentigo malignalentigo malignaMedDRA version: 12 Level: LLT Classification code 10024218 Term: lentigo malignaEUCTR2009-016909-42-GBniversity Hospitals Birmingham NHS Foundation Trust40
进行中（未招募）
1 期
Topical Imiquimod in Treating Patients with Grade 2/3 Cervical Intraepithelial Neoplasia - ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-TrialGrade 2/3 Cervical Intraepithelial NeoplasiaMedDRA version: 9.1Level: LLTClassification code 10049701Term: Cervical intraepithelial neoplasia IIMedDRA version: 9.1Level: LLTClassification code 10049702Term: Cervical intraepithelial neoplasia IIIEUCTR2008-007763-16-ATMedizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Gynäkologie und Gyn.Onkologie60