NCT00002212已完成2 期
Phase II Evaluation of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give Targretin capsules to patients with AIDS-related Kaposi's sarcoma (KS).
详细描述
This is a multicenter, open-label study to evaluate the safety and efficacy of Targretin capsules in patients with AIDS-related KS. NOTE: The daily dose may be reduced as necessary for toxicity management.
研究设计
- 研究类型
- Interventional
- 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:
- •Serum HIV antibody positive by ELISA.
- •KS documented by biopsy (repeat biopsy is not required for entry if KS has been previously confirmed histologically and the histopathology report has been reviewed).
- •A minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions, each of which has been present for at least 30 days or has a longest dimension of at least 10mm, and has not received prior local or topical therapy within 60 days of study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Concurrent, serious, uncontrolled infection including, but not limited to:
- •Mycobacterium avium intracellulare or other mycobacterium infection; Pneumocystis carinii pneumonia; CMV retinitis or colitis; Toxoplasma brain abscess; Cryptococcal meningitis.
- •Serious intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.
- •Known allergy or sensitivity to retinoid class drugs.
- •Concurrent Medication:
- •Local or topical therapy such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy to any KS indicator lesion.
- •Systemic anticancer chemotherapy, systemic anticancer hormonal therapy, and/or systemic anticancer immunotherapy.
- •Systemic use of retinoid class drugs, beta-carotene compounds, or Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) for any indication.
- •Human chorionic gonadotropin.
- •Concurrent Treatment:
- •Radiotherapy, cryotherapy, photodynamic therapy, and/or laser therapy for any KS indicator lesion.
- •Prior Medication:
- •Systemic treatment of KS within 30 days of study entry.
- •Systemic treatment with either Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) or other retinoid class drugs for any indication within 30 days of study entry.
- •Previous local or topical therapy of any KS indicator lesion such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy within 60 days of study entry.
- •Prior Treatment:
- •Radiotherapy, cryotherapy, photodynamic therapy and/or laser therapy within 60 days of study entry.
研究者
研究点 (3)
Loading locations...
相似试验
已完成
3 期
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung CancerNon-small Cell Lung CancerNCT00050960Eisai Inc.612
已完成
3 期
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung CancerNon-small Cell Lung CancerNCT00050973Eisai Inc.623
暂停
2 期
Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC)Breast CancerMetastatic Breast CancerNCT06214793Megan Kruse, MD61
已完成
不适用
Special Drug Use Results Survey of Targretin capsules 75-mg in patients with Cutaneous T-cell LymphomasCutaneous T-Cell LymphomasJPRN-UMIN000022568Minophagen Pharmaceutical Co., Ltd.200
招募中
不适用
Special Drug Use-results Survey of Targretin Capsules combined with photo(chemo)therapyCutaneous T-cell lymphomaJPRN-jRCT2031210625pharmacovigilance departmant70