RPCEC00000206尚未招募1 期
Open, single-center,clinical trial with racotumomab-alum vaccine in pediatric patients diagnosed with neuroblastoma, Ewing sarcoma or nephroblastoma.
Center of Molecular Immunology (CIM)0 个研究点目标入组 10 人开始时间: 2015年12月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- 1 year 至 18 years（—）
- 性别
- All
入选标准
- •1. Patients older than 1 year of age and under 19 years.
- •2. Patients who meet the diagnostic criteria.
- •3. Patients in which the period between the end of the last oncoespecifica therapy and study inclusion is not less than 30 nor more than 60 days.
- •4. Voluntary patient and / or family or guardian to participate in the study by signing the informed consent model.
- •5. Patients who are using contraceptive methods if sexually active
- •6. Patients with histologically confirmed tumors that express NeuGc-GM3 in tumor tissue.
- •7. General health as Karnofsky index (KPS) = 50% (over 16 years), Lansky = 50% (for those under 16 years)
- •8. Patients with a life expectancy = 3 months
- •9. Laboratory parameters within normal limits defined as:
- •- Hematology: Hemoglobin = 100 g / L, absolute neutrophil count = 1500 cells / L, platelets = 100x109 / L
- •- Liver function: Within normal limits defined by TGP, TGO = 2.5 above the reference value
- •- Renal function: Serum creatinine = 1.5 above the reference value.
- •¿No es correcto?
- •1. Patients older than 1 year of age and under 19 years.
- •2. Patients who meet the diagnostic criteria.
- •3. Patients in which the period between the end of the last oncoespecifica therapy and study inclusion is not less than 30 nor more than 60 days.
- •4. Voluntary patient and / or family or guardian to participate in the study by signing the informed consent model.
- •5. Patients who are using contraceptive methods if sexually active
- •6. Patients with histologically confirmed tumors that express NeuGc-GM3 in tumor tissue.
- •7. General health as Karnofsky index (KPS) = 50% (over 16 years), Lansky = 50% (for those under 16 years). (Annex 2)
- •8. Patients with a life expectancy = 3 months
- •9. Laboratory parameters within normal limits defined as:
- •- Hematology: Hemoglobin = 100 g / L, absolute neutrophil count = 1500
- •cells / L, platelets = 100x109 / L
- •- Liver function: Within normal limits defined by TGP, TGO = 2.5
- •above the reference value
- •- Renal function: Serum creatinine = 1.5 above the reference value
排除标准
- •1. Patients participating in another clinical trial.
- •2. Patients who are pregnant or nursing
- •3. Patients with a history of encephalopathy, seizures or severe allergies.
- •4. Patients who at the time of inclusion present associated chronic diseases in decompensation stage.
- •5. Patients who present a history of hypersensitivity to the product or any component
- •6. Patients with febrile states, and / or severe septic processes.
- •7. Patients with immunosuppressive disease or HIV positive.
- •8. Patients who have been treated with specific immunotherapy in the 6 months prior to inclusion in the study.
研究者
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