NCT01882946Unknown1 期
A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the treatment of solid tissue tumors will be identified, followed by a Phase II component to determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability to reduce tumor growth.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years (inclusive) at screening.
- •Karnofsky performance status (KPS) of 70 or higher or Eastern Cooperative Oncology Group (ECOG) 0-1 at screening.
- •Subjects with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which primary treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment, with the understanding that DCVax-Direct is not intended as a treatment of last resort.
- •Not eligible for complete resection due to either tumor location, physician's assessment or subject's choice.
- •Must have completed at least one recent treatment regimen in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden.
- •Any steroid therapy >2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis.
- •At least one measurable tumor mass, i.e. a lesion that can accurately be measured by CT/MRI in at least one dimension with longest diameter ≥ 1 cm, that is accessible for injection either with or without imaging (CT/ultrasound) guidance.
- •Adequate hematological, hepatic, and renal function,
- •Adequate blood coagulation parameters
- •Life expectation of >3 months.
排除标准
- •Positive HIV-1, HIV-2, or Human T-lymphotropic virus (HTLV-I/II) tests.
- •History of current or prior (within the last two years) active clinically significant malignancy other than the tumor type for which DCVax-Direct treatment is considered, and except for primary tumor in the case of metastases and adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •Heavily pretreated (HP) subjects are not eligible for this study, unless treatments have occurred more than 1 year in the past.
- •Presence of brain metastases, unless treated surgically and/or irradiated and clinically stable off steroids or on low dose (< 2 mg per day) steroids for ≥ 14 days, or presence of leptomeningeal disease.
- •History of immunodeficiency or unresolved autoimmune disease.
- •Requirement for ongoing immunosuppressants.
- •Prior active immunotherapy for cancer within the past 2 years.
- •Ongoing medical need for continuous anti-coagulation or anti-platelet medication.
- •Known genetic cancer-susceptibility syndromes.
- •Acute or active uncontrolled infection
- •Ongoing fever ≥ 101.5 degrees F/38.6 degrees C at screening.
- •Unstable or severe intercurrent medical conditions such as unstable angina, uncontrolled arrhythmias, Crohn's Disease, ulcerative colitis etc.
- •Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm).
- •Allergy or anaphylaxis to any of the reagents used in this study.
- •Inability to obtain informed consent because of psychiatric or complicating medical problems.
- •Inability or unwillingness to return for required visits and follow-up exams.
研究组 & 干预措施
DCVax-Direct
Experimental
DCVax-Direct: autologous, activated dendritic cells for intratumoral injection
干预措施: DCVax-Direct (Biological)
结局指标
主要结局
Number of patients with adverse events
时间窗: 6 months
次要结局
- Number of patients with tumor response(18 months)
研究者
研究点 (2)
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