NCT00961844终止1 期
Phase I/II Trial for Vaccine Therapy With Dendritic Cells - Transfected With hTERT-, Survivin- and Tumor Cell Derived mRNA + ex Vivo T Cell Expansion and Reinfusion in Patients With Metastatic Malignant Melanoma
Steinar Aamdal1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and toxicity of vaccination with DC transfected h-TERT mRNA, survivin mRNA and tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion in patients with metastatic malignant melanoma.
研究概览
简要总结
In this trial the investigators want to combine chemotherapy with immunotherapy by giving the patients Temozolomide, before vaccination. The investigators have also included hTERT and survivin mRNA in the vaccine. Finally, the investigators want to introduce ex vivo T cell expansion after lymphodepletion for the patients who show an immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •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
- •If the patient is female, she must practice adequate contraception during the study treatment
- •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
排除标准
- •The patient suffers from an ocular- or mucous membrane melanoma
- •History of prior malignancy other than melanoma, except for curatively treated basal 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 enrollment
- •Autoimmune disease currently being treated with systemic steroids Version no. 3, 18 June 2009 Page 17 of 50
- •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
- •Positive for HIV, Hepatitis B and C and Syphilis (treponema pallidum)
- •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, glucocorticosteroids or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination
- •No treatment with dacarbazine or temozolomide at any time prior to study entry
- •Any reason why, in the opinion of the investigator, the patient should not participate
研究组 & 干预措施
DC vaccine + Temozolomide
Experimental
Dendritic cell loaded with h-TERT mRNA, survivin mRNA and autologous tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion.
干预措施: Temozolomide (Drug)
DC vaccine + Temozolomide
Experimental
Dendritic cell loaded with h-TERT mRNA, survivin mRNA and autologous tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion.
干预措施: Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion (Biological)
结局指标
主要结局
Safety and toxicity of vaccination with DC transfected h-TERT mRNA, survivin mRNA and tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion in patients with metastatic malignant melanoma.
次要结局
- Evaluation of immunological responses, time to disease progression and survival time.(5 years of follow-up.)
研究者
Steinar Aamdal
MD, PhD
Oslo University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
2 期
To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic AcidSmall Cell Lung CancerNCT00617409H. Lee Moffitt Cancer Center and Research Institute69
终止
2 期
Dendritic Cell (DC)/Myeloma Fusions in Combination With Nivolumab in Patients With Relapsed Multiple MyelomaMultiple MyelomaNCT03782064Beth Israel Deaconess Medical Center5
终止
1 期
Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic CancerPancreatic CancerNCT02548169Baylor Research Institute7
进行中（未招募）
2 期
DC/AML Fusion Cell Vaccine vs Observation in Patients Who Achieve a Chemotherapy-induced RemissionAcute Myelogenous LeukemiaNCT03059485Beth Israel Deaconess Medical Center82
已完成
1 期
Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving TrastuzumabHER2/Neu PositiveHLA-A2 Positive Cells PresentStage IV Breast CancerStage IV Ovarian CancerNCT00194714University of Washington22