EUCTR2015-001712-35-FR进行中（未招募）1 期
ANTICANCER THERAPEUTIC VACCINATION USING TELOMERASE-DERIVED UNIVERSAL CANCER PEPTIDES IN METASTATIC NON SMALL CELL LUNG CANCER - UCPVax
Centre Hospitalier Régional Universitaire de Besançon0 个研究点开始时间: 2015年7月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1- Male or female patients, age = 18 and = 89 years old
- •2- Written informed consent
- •3- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- •4- Stage IIIB not amenable to radiotherapy or stage IV cancer according to the TNM classification (7th edition ref) or recurrent NSCLC after surgery not amenable to loco-regional therapy.
- •5- Pre-treated with at least 2 lines of systemic treatment (chemotherapy or targeted therapy) with a delay of at least three weeks between the last chemotherapy treatment and the first UCPVax injection, or 3 days after three last tyrosine kinase inhibitor dose and the first UCPVax injection. Chemoradiation for stage IIIB disease is considered as one treatment line.
- •6- At least one measurable lesion by CT scan or MRI based on RECIST criteria version 1.1
- •7- Performance status 0 or 1 on the ECOG scale
- •8- Life-expectancy > 3 months
- •9- Adequate hematological, hepatic, and renal function:
- •oHemoglobin = 10.0 g/dL
- •oWhite blood cells (WBC) = 3.0 x 109/L including neutrophils = 1.5 x 109/L and total lymphocytes count = 1.0 x 109/L
- •oPlatelets count = 100 x 109/L
- •oSerum alkaline phosphatase = 3 x ULN in the absence of liver or bone metastases and = 5 x ULN in patients with documented bone or liver metastases
- •oSerum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] = 2.5 x ULN in the absence of liver metastases and = 5 x ULN in case of liver metastases.
- •oTotal bilirubin = 1.5 x ULN
- •oGlomerular Filtration Rate = 60 mL/min (according to Modification of the Diet in Renal Disease [MRDR] formula or Cockroft & Gault formula)
- •oSerum albumin = 30 g/L
- •10- Effective contraception during the study period and for 1 month after the last study treatment administration. Male patients with a partner at risk of pregnancy should use an appropriate contraception method.
- •11- Affiliation to French social security or receiving such a regime.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1- Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
- •2- Symptomatic brain metastases. Patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included.
- •3- History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
- •4- Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone = 10 mg/day is allowed) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment
- •5- Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs
- •6- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
- •7- Pregnancy or lactating patients.
- •8- Patients with any medical or psychiatric condition or disease,
- •9- Patients under guardianship, curatorship or under the protection of justice.
研究者
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