An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and a Comparison to Subcutaneous (SC) Injection in Human Immunodeficiency Virus (HIV) Subjects Diagnosed With Kaposi Sarcoma (KS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To Determine the Safety of Escalating Doses of Tc 99m Tilmanocept in HIV Subjects With Biopsy-confirmed KS.
研究概览
简要总结
To determine the safety of escalating IV doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS and to compare results obtained from subcutaneous and IV administrations of Tc 99m tilmanocept in the same subjects.
详细描述
This is a Manocept Platform prospective, single-center, open-label, non-randomized, dose escalation, comparative, safety study of intravenously and subcutaneously injected Tc 99m tilmanocept in the localization and detection of cutaneous and non-cutaneous KS tumor(s) in subjects with biopsy-confirmed KS. Three IV doses (µg/mCi) of tilmanocept will be evaluated in three cohort groups. One subcutaneous dose will be evaluated in cohort group 3.
This study is designed to evaluate the safety and tolerability of escalating doses of IV Tc 99m tilmanocept and to compare results obtained from IV and subcutaneous administrations of Tc 99m tilmanocept in the same subjects. Whole body planar as well as SPECT/CT imaging will be performed to provide greater resolution of areas of Tc 99m tilmanocept localization. A biopsy of a non-visceral KS lesion will be taken to correlate pathology with Tc 99m tilmanocept localization.
This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in HIV-positive subjects with known KS by evaluating localization in known and unknown cutaneous and non-cutaneous lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- •The subject has provided written informed consent with HIPAA authorization before the initiation of any study-related procedures.
- •The subject is at least 18 years of age at the time of consent.
- •The subject is HIV positive.
- •The subject has a biopsy-confirmed diagnosis of KS and is classified into one of the categories below:
- •Confirmed cutaneous KS/oral lesions without edema.
- •Confirmed cutaneous KS/oral lesions with edema.
- •Confirmed cutaneous KS/oral lesions with or without edema and suspected non-cutaneous KS due to clinical symptomology or confirmed non-cutaneous KS lesion(s).
排除标准
- •The subject is pregnant or lactating.
- •The subject has received chemotherapy or radiation therapy to KS sites within six weeks of enrollment.
- •The subject has known sensitivity to dextran.
- •The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration on Day
- •The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept on Day
- •Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
研究组 & 干预措施
100 mcg/5 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
干预措施: Tc99m-tilmanocept (Drug)
100 mcg/10 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
干预措施: Tc99m-tilmanocept (Drug)
200 mcg/5 mCi Tc99m-Tilmanocept
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
干预措施: Tc99m-tilmanocept (Drug)
结局指标
主要结局
To Determine the Safety of Escalating Doses of Tc 99m Tilmanocept in HIV Subjects With Biopsy-confirmed KS.
时间窗: 10 days after IV Tc 99m tilmanocept administration
Cohort 1 (100 mcg/ 5mCi) was conducted first. A safety data review meeting was held after completion of Cohort 1 and again after completion of Cohort 2 at which the principal investigators and sponsor representatives reviewed the safety data to determine whether to proceed to the next cohort. All cohorts were evaluated for safety. Safety evaluations included AEs, clinical laboratory tests, vital signs, physical examinations, and ECGs. The data table includes the number of safety signals detected during the evaluation for each cohort.
次要结局
- Per Subject Localization Rate of Tc 99m Tilmanocept in at Least One KS Suspected or Confirmed Lesion by Planar and/or SPECT/CT Imaging(10 days after IV Tc 99m tilmanocept administration)
- Localization Concordance of Subcutaneous Injection and IV Injection(10 days after IV Tc 99m tilmanocept administration)
- Qualify and Quantify Tc 99m Tilmanocept Localization Intensity on Imaging With CD206 Locale and Quantity by Histology and IHC in Biopsied KS Lesions to Determine Optimal IV Dose.(10 days after IV Tc 99m tilmanocept administration)
- Exploratory: Quantify HHV8 in Biopsied KS Lesions. Mean and Standard Deviation Results.(10 days after IV Tc 99m tilmanocept administration)
- Exploratory: Quantify HHV8 in Biopsied KS Lesions. Median Results.(10 days after IV Tc 99m tilmanocept administration)