EUCTR2008-006253-41-NO进行中（未招募）1 期
Phase I/II trial for vaccine therapy with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion in patients with metastatic malignant melanoma
The Norwegian Radium Hospital, Oslo University Hospital0 个研究点目标入组 25 人开始时间: 2008年10月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically verified malignant melanoma with measurable (according to RECIST), unresectable metastases (Stage III or Stage IV M1a-c as defined by criteria of the AJCC Cancer Staging Manual, 6 th. Edition 2002). Patients with a melanoma of an unknown primary site are eligible
- •Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA)
- •Must be at least 18 years of age
- •Must be ambulatory with a ECOG performance status 0 or 1
- •Life expectancy = 6 months
- •Negative MRI of the brain
- •Must have lab values as the following:
- •?ANC = 1.5 x 109/L
- •?Platelets = 100 x 109/L
- •?Hb = 9 g/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
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patient suffers from an ocular- or mucous membrane melanoma
- •History of prior malignancy other than melanoma, with the exception of curatively treated basel cell or squamous cell carcinoma of the skin and cervix cancer stage 1B or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured
- •Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune systems. PI shall make the final determination regarding appropriateness of enrolment
- •Autoimmune disease currently being treated with systemic 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
- •Pregnancy or lactation
- •If the patient has received any prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents, this must have been stopped at least 4 weeks before first study treatment administration.
- •Chemotherapy, glucocorticosteroides or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination
- •No treatment with dacarbazin or temozolomide at any time prior to study entry
- •Any reason why, in the opinion of the investigator, the patient should not participate
研究者
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