Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC): A Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
The purpose of this study is to test the safety of a course of injections containing Poly-ICLC in patients with advanced solid tumors that can be easily and safely reached with a needle.
Poly-ICLC is a compound that has been used to help the body in its fight against cancer.
详细描述
We hypothesize that this therapeutic in-situ autovaccination strategy is comprised of three immunomodulatory steps. The first is the innate immune local tumor killing induced by intratumoral Hiltonol (via NK, TNF, etc). A very close second step is optimal Th1-weighted priming through the in-situ combination of the poly-ICLC danger signal with the tumor antigens released in step 1 and further processed and cross-presented by poly-ICLC activated mDC, etc. The repeated administration of the Hiltonol danger signal IT in the context of the patient's own tumor antigens and in a way that mimics a natural viral infection may be critical to this step. Once the system is optimally primed, the third step is targeting and maintenance of the immune response and its facilitation at remote tumor sites with IM poly-ICLC through chemokine release, inflammasome activation and other costimulatory factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of melanoma, squamous head and neck cancer, sarcoma, squamous cell carcinoma of the skin, basal cell skin cancer, or breast cancer
- •Sarcoma Patients must be @ least14 yrs of age; all others 18 yrs of age or older.
- •Un-resectable disease. Patients with resectable disease may be enrolled after having refused surgery and documented consultation with a surgeon.
- •Disease progressed through @ least 1 systemic therapy or through local irradiation within the preceding 6 mos.
- •Radiologically or visually measurable recurrent or metastatic disease and @ least 10mm in longest dimension.
- •At least 1 accessible primary or metastatic tumor site that can be readily injected IT with poly-ICLC with or without ultrasound guidance. Lesion can be superficial cutaneous, subcutaneous or within a readily accessible lymph node & must measure @ least 10mm in longest dimension.
- •Tumor site injection cannot have been irradiated within 8 wks of C1D1
- •ECOG performance status ≤
- •Normal hematologic, renal & liver function. INR<2 if off of anticoagulation. Patients on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the investigator.
- •Patients able to provide informed consent.
- •Must agree to follow acceptable birth control methods and continue for @ least 2 mos. after last poly-ICLC dose. Women of childbearing potential must have a (-) pregnancy test.
排除标准
- •Serious concurrent infection or medical illness.
- •Bulky intracranial metastatic disease with shift of midline structures or progressive brain metastasis. Administration of immunotherapy or conventional chemotherapy treatments for metastatic cancer within 4 wks of C1D1
- •Radiation treatments within 4 wks of C1D1
- •AIDS defined as a CD4 count < then 200 in the context of HIV sero-positivity or chronically is taking immunosuppressive medication such as steroids or transplant related medications.
- •Life expectancy of < than 6 mos.
研究组 & 干预措施
IT and IM injections Poly-ICLC
Enrolled patients will receive two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.
干预措施: Poly-ICLC (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: average 52 weeks
Progression-free survival defined as the time in weeks from study entry until tumor progression defined using the Wolchok criteria or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date. In order to minimize the potential for misdiagnosis of pseudoprogression, related to early inflammation, tumor measurement for determination of progression will be made at the earliest at 26 weeks.
次要结局
- Therapeutic Effect in Treated Patients(24 months)
研究者
Nina Bhardwaj
Director, Immunotherapy Program
Icahn School of Medicine at Mount Sinai