NCT01278940已完成1 期
Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma
Oslo University Hospital0 个研究点目标入组 31 人开始时间: 2002年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs
研究概览
简要总结
PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs .
SECONDARY OBJECTIVES:Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Accessible tumour tissue for vaccine production (extraction of tumour mRNA) i.e.subcutaneous or lymph node metastases.
- •Must be at least 18 years of age.
- •Must have histologically confirmed advanced, metastatic cutaneous melanoma no longer amenable for surgery.
- •Must have evidence of disease progression and measurable or evaluable metastases
- •Must be ambulatory with a ECOG performance score of <2
- •Must have lab.values as following :
- •ANC > 1.5 x 109/L; platelets > 100 x 109/L, Hb > 9g/dL (> 5.6 mmol/L). Creatinine < 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance > 40 mL/min, Bilirubin < 20% above the upper limit of normal, ASAT and ALAT < 2.5 the upper limit of normal. Albumin > 2.5 g/L.
- •Prior radiotherapy: A minimum of 4 weeks (8 weeks in case of extensive radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol.
- •Prior chemotherapy: A minimum 4 weeks must have elapsed between the end of the prior chemotherapy and entry into the protocol.
- •Signed informed consent of the patients for the treatment and follow up must be obtained and documented according to the ICH-GCP Guidelines.
排除标准
- •History of prior malignancy other than melanoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervix stage 1B.
- •Active infection requiring antibiotic therapy.
- •Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- •Autoimmune disease currently treated with steroids.
- •Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
- •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
- •Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
- •Pregnancy or lactation.
- •Any reason why, in the opinion of the investigator, the patient should not participate.
结局指标
主要结局
Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs
时间窗: Patients are coming every week during 6 weeks.
Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints.
次要结局
- Assessment of tumour response.(3 months after study start)
- Determine immunological response to the vaccine (induction of specific T-cell response)(6 weeks and 3 months after study start)
研究者
Svein Dueland
MD, PhD
Oslo University Hospital
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