A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intratumorally in Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Registration of adverse events as a measure of safety and tolerability
研究概览
简要总结
The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"? Patients newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will be eliminated. Adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters. Immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.
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
- •Be informed of the nature of the study and have provided written informed consent
- •At least 18 years of age.
- •Diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one distant lymph node metastasis.
- •Tumor size (renal cell carcinoma; primary tumor) at least 4.0 cm in longest diameter as measured by CT. Distant metastasis at least 1 cm diameter as measured by CT or a distant lymph node metastasis at least 2,5 cm diameter as measured by CT. Clinical stage 'T1b or more; NX; M1'
- •Adequate hematological parameters, i.e:
- •B-Leukocyte count ≥ 4.5 x 109/L B-Platelet count ≥ 150 x109/L B-Haemoglobin ≥ 100 g/L
- •Women of Childbearing Potential (WOCBP) should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
排除标准
- •Performance status > ECOG 2 after optimization of analgesics
- •Adequate coagulation parameters, i.e: P-Prothrombin complex (PK), P-APT time
- •Ongoing treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 28 days before first vaccination.
- •Previously known or ongoing active autoimmune disease which requires treatment with systemic immunosuppressive agents. E.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases.
- •Patients with previous or ongoing skin malignancy (basal-cell carcinoma, squamous cell carcinoma, melanoma), other hematological or solid malignancy or blood dysfunctions.
- •Ongoing infection that requires treatment with antibiotics.
- •Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
- •Known malignancy in CNS.
- •Active or latent virus disease (HIV, HBV and HCV).
- •Ongoing pregnancy or lactation. Females needs to have negative pregnancy test at screening visit.
- •Life expectancy less than 3 months.
- •Concomitant exposure to other investigational products.
- •Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.
结局指标
主要结局
Registration of adverse events as a measure of safety and tolerability
时间窗: 1 year 3 months (Feb 2012-May 2013)
Changes in vital signs from baseline (heart rate, blood pressure, body temperature) as a measure of safety and tolerability
时间窗: 1 year 3 months (Feb 2012 - May 2013)
Changes in lab parameters from baseline as a measure of safety and tolerability
时间窗: 1 year 3 months (Feb 2012 - May 2013)
次要结局
- Immunologic response in blood (immunologic panel) measured with ELISPOT.(1 year 3 months (Feb 2012 - May 2013))
- Examination of immunohistology parameters (macrophage marker, CD3, CD4, CD8, CD56) of the renal tumor post nephrectomy.(1 year 3 months (Feb 2012 - May 2013))
- CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy(1 year 3 months (Feb 2012 - March 2013))
- CT evaluation to evaluate number of metastases 3 months post nephrectomy.(1 year 3 months (Feb 2012 - May 2013))
- Changes in body weight 3 months post nephrectomy vs. baseline.(1 year 3 months (Feb 2012 - May 2013))
- Changes in WHO-ECOG 3 months post nephrectomy vs. baseline.(1 year 3 months (Feb 2012 - may 2013))