NCT01883518Unknown1 期
Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma
N.N. Petrov National Medical Research Center of Oncology2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
研究概览
简要总结
The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas
详细描述
Vaccination is carried out on the planned days ± 3 days
- All examinations must be performed before the vaccine is administered.
- Full physical examination.
- Assessment of vital signs (blood pressure, temperature, heart rate), the general condition of the patient and physical activity.
- Evaluation of concomitant therapy.
- Assessment of vital signs.
- Laboratory safety and immunological indicators
- Assessment of adverse events, symptoms and syndromes of the disease.
- Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use)
- After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 18 or older
- •ECOG performance score 0 or 1
- •Histologically proven soft tissue sarcoma
- •Unresectable or metastatic soft tissue sarcoma
- •Ability to give written informed consent
- •Objective measured and measurable tumor lesions
- •The failure of standard therapy
- •Adequate amount of material for genetic research
- •No active or chronic infection with HIV, Hepatitis B or Hepatitis C
- •Men/Women of childbearing potential must use adequate contraception
- •Hematology, liver function and renal function lab tests within required parameters
排除标准
- •Untreated or uncontrolled brain metastases.
- •History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma.
- •Autoimmune disease (vitiligo is not a basis for exclusion).
- •Serious uncontrolled medical disorder or active infection that would impede treatment.
- •Underlying medical or psychiatric condition that would cause administration vaccine
- •Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine
- •Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed).
- •Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements.
- •Pregnant or breastfeeding women.
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.
结局指标
主要结局
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
时间窗: 6 month
Achieving a six-month time to progression (PFS) 40% of patients receiving ADKV loaded with allogeneic tumor lysate expressing PTA in patients with soft tissue sarcomas
次要结局
- Median overall survival(6 month)
- Median progression-free survival(6 month)
- Objective response rate(6 mounth)
- Assess biological response of tumors(6 mounth)
研究者
研究点 (2)
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