NCT00002167已完成2 期
Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
Clinical Solutions12 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 12
研究概览
简要总结
To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT.
详细描述
All patients receive a single dose of SnET2 and are randomized to receive either PDT light treatment or no light treatment (control group). Patients are assessed prior to and at 4, 12 and 24 weeks following treatment, and are followed for 7 months.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Patients must have:
- •Documentation of at least one biopsy-confirmed KS lesion.
- •A minimum of 4 and no more than 36 KS lesions.
- •All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and <= 40 mm in diameter of the longest bidimensional axis.
- •ACTG disease state T(0) L(0) or (1) S(0) or (1).
- •Life expectancy greater than 6 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Active opportunistic infection or condition except thrush or herpes simplex virus infections.
- •Advanced KS tumor stages including the presence of tumor associated edema or ulceration, extensive oral KS, or KS in other non-nodal viscera.
- •Hematopoietic dysfunction.
- •Coagulation dysfunction.
- •Hepatic dysfunction.
- •Renal dysfunction.
- •Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction.
- •Pulmonary dysfunction.
- •Known disorder of lipoprotein metabolism or clearance.
- •Patients with the following prior conditions are excluded:
- •History of allergic or hypersensitivity reactions to light, egg proteins or egg yolks, history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- •Excluded within 7 days of therapy:
- •Hematopoietic dysfunction.
- •Coagulation dysfunction.
- •Hepatic dysfunction.
- •Renal dysfunction.
- •Excluded within 3 months of therapy:
- •Pulmonary dysfunction.
- •Excluded within 6 months of therapy:
- •Myocardial infarction.
- •Prior Medication:
- •Intralesional chemotherapy within the past 12 weeks.
- •Systemic chemotherapy or investigational drugs within the past 4 weeks.
- •Prior Treatment:
- •Excluded within 3 months prior to therapy:
- •Local cryotherapy or surgery to study lesions.
- •Systemic or topical photodynamic therapy agents.
研究者
研究点 (12)
Loading locations...
相似试验
撤回
不适用
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic KeratosesActinic KeratosisNCT00814528University of Chicago
Unknown
不适用
Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in SituSquamous Cell CarcinomaNCT03025724Rhode Island Hospital40
终止
1 期
Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the SkinHead and Neck CancerMetastatic CancerNon-melanomatous Skin CancerLymphomaSarcomaBreast CancerNCT00023790Case Comprehensive Cancer Center3
撤回
2 期
Photodynamic Therapy in the Treatment of Malignant Intracranial TumorsMalignant Intracranial TumorsAnaplastic AstrocytomasAnaplastic OligodendrogliomasAnaplastic EpendymomaGlioblastoma MultiformeNCT00243490National Taiwan University Hospital5
招募中
不适用
Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of PeriodontitisPeriodontitisNCT06305533University of Baghdad18