EUCTR2012-000552-33-NL进行中（未招募）不适用
Adoptive T cell therapy plus vaccination in metastatic melanoma patients - ACT in melanoma.
eiden University Medical Center0 个研究点开始时间: 2012年11月29日最近更新:
试验速览
- 阶段
- 不适用
- 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. Age = 18 years.
- •2. Histologically proven melanoma.
- •3. Melanoma must be at one of the following AJCC 2009 stages:
- •-Irresectable (or residual) regional metastatic melanoma, i.e. in terms of AJCC 2009 classification irresectable stage III melanoma, or
- •-Stage IV melanoma, i.e. distant metastatic disease (any T, any N, M1a, M1b or M1c), and normal LDH.
- •4. Patients with brain metastases have to be neurologically stable for at least 2 months and should not use dexamethasone.
- •5. Presence of measurable progressive disease according to RECIST version 1.1.
- •6. Expected survival of at least 3 months.
- •7. WHO performance status =1.
- •8. Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified :
- •Lab ParameterRange
- •Hemoglobin= 6,0 mmol/l
- •Granulocytes= 1,500/µl
- •Lymphocytes= 700/µl
- •Platelets= 100,000/µl
- •Creatinine clearance= 60 min/ml
- •Serum bilirubin= 40 µmol/l
- •ASAT and ALAT= 5 x the normal upper limit
- •LDH= 2 x the normal upper limit
- •9. Viral tests:
- •-Negative for HIV type 1/2, HTLV and TPHA
- •-No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum
- •-No antibodies against HCV (hepatitis C virus) in the serum
- •10. Able and willing to give valid written informed consent.
- •11. Successful production of melanoma reactive T cells and autologous tumor cells that meet the release criteria
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients will be excluded from the study for any of the following reasons:
- •1. Prior treatment, including immunotherapy e.g. with Ipilimumab, is not an exclusion criterion. Systemic therapy must have been discontinued for at least four weeks before study entry. Radiotherapy and MEK-inhibitor/BRAF-inhibitor should be discontinued for at least two weeks before study entry. Patients should have PD after treatment. After treatment with Ipilimumab initial PD should be confirmed by repeated imaging studies evaluated according to irRC to exclude late effects of Ipilimumab treatment.
- •2. Patients with brain metastases who are neurologically unstable and/or on use of dexamethasone.
- •3. Clinically significant heart disease (NYHA Class III or IV).
- •4. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
- •5. Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
- •6. Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma.
- •7. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •8. Lack of availability for follow-up assessments.
- •9. Pregnancy or breastfeeding.
研究者
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