Phase I Study of Topical Romidepsin in Early Stage Cutaneous T-cell Lymphoma

局部用罗米地辛治疗早期皮肤 T 细胞淋巴瘤的 I 期研究

• 批准号: 8349233
• 负责人: Heidi Kong
• 金额: $ 10.14万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8349233
• 关键词: Adverse effects; Biological Assay; Biological Markers; Biopsy; Blood; CD4 Positive T Lymphocytes; Cancer Therapy Evaluation Program; Carmustine; Chronic; Clinical Trials; Clinical trial protocol document; Cutaneous; Cutaneous Lymphoma; Depsipeptides; Disease; Dose; Dose-Limiting; Drug Kinetics; Early treatment; Electron Beam Therapy; Enrollment; Erythema; Evaluation; Ficusin; Histology; Histone Deacetylase Inhibitor; Histone deacetylase inhibition; Immunohistochemistry; Individual; Ionizing radiation; Mechlorethamine; Mycosis Fungoides; Non-Hodgkin' s Lymphoma; Patients; Pharmaceutical Preparations; Photography; Phototherapy; Physical Examination; Pruritus; Psoralens; Quality of life; Radiation; Radiation therapy; Recruitment Activity; Recurrence; Refractory; Research; Risk; Safety; Skin; Skin Cancer; Staging; T-Cell Lymphoma; Time; Toxic effect; Ultraviolet Rays; Uncertainty; Vorinostat; Work; cost; effective therapy; phase 1 study; research study; skin disorder

In this clinical trial protocol of the safety and efficacy of topical romidepsin (depsipeptide) in early stage mycosis fungoides (a rare type of skin lymphoma), each dose level evaluation includes repeated assessments of skin disease through physical examination, medication tolerability, pruritus, quality of life, erythema with the use of colorimeter, photography using a standardized studio set-up, research blood for side effect evaluation and pharmacokinetics, and skin biopsies for routine histology and special research studies. We encountered a dose limiting skin toxicity within this fiscal year. As a result, we worked on recruiting additional subjects for that dose level. However, due to technical issues in the immunohistochemistry assays indicating uncertainty regarding inhibition of histone deacetylase, further recruitment has been temporarily held. We have been working with collaborators and CTEP to resolve these technical issues prior to further enrollment.

在本临床试验方案中，局部罗米地辛的安全性和有效性（缩肽）在蕈样肉芽肿早期（一种罕见类型的皮肤淋巴瘤），每个剂量水平评价包括通过体格检查重复评估皮肤疾病、药物耐受性、瘙痒、生活质量、使用比色计的红斑、使用标准化工作室设置的摄影，用于副作用评估和药代动力学的研究血液，以及用于常规组织学和特殊研究的皮肤活检。我们在本财政年度内遇到了剂量限制性皮肤毒性。因此，我们致力于招募该剂量水平的额外受试者。然而，由于免疫组织化学检测中的技术问题表明关于组蛋白去乙酰化酶抑制的不确定性，进一步的招募已暂时停止。我们一直在与合作者和CTEP合作，以在进一步入组之前解决这些技术问题。