EUCTR2008-007515-33-SE进行中（未招募）不适用
A multi-centre, two-arm, randomized, open, phase II study of adaptive design investigating SentoClone® compared to reference treatment in advanced malignant melanoma
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •To be eligible for inclusion in this study, the patients must fulfil all of the following criteria:
- •1.Surgically incurable stage III or IV malignant melanoma
- •2.At least one measurable lesion
- •3.WHO performance status 0-1
- •4.Life expectancy > 3 months
- •5.Diagnosed metastasis
- •6.One tumour draining lymph node surgically accessible
- •7.Measurable tumour manifestation after the harvest of tumour tissue and sentinel/metinel nodes*
- •8.Signed informed consent
- •*Should be fulfilled after surgery (visit 2) for patients randomised to SentoClone®.
- •Are the trial subjects under 18? yes
- •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
- •To be eligible for inclusion in this study the patients must not meet any of the following criteria:
- •1.Known allergy against used trace substance patent blue and/or albumin technetium (Nanocoll)
- •2.Known allergy against gentamicin and/or phenol red
- •3.Any condition (medical, social, psychological or legal) that influences adequate information negatively or is considered to be a problem for the patient to cope with treatment and follow-up
- •4.Aplastic anaemia or myelofibrosis
- •5.Previous treatment with temozolomide or dacarbazine, or any other chemotherapy during the last 3 months
- •6.Disease progression following treatment with temozolomide or dacarbazine more than 3 months back 1
- •7.Previous radiotherapy of target lesion(s) or tumour draining lymph nodes which will be used for lymphocyte extraction 2
- •8.Ongoing systemic steroid treatment or other treatment influencing immune defence
- •9.History of other malignant tumour disease apart from adequately treated basalioma or squamous cell carcinoma of the skin more than 5 years ago
- •10.Positive test(s) for HIV and/or Hepatitis B and/or Hepatitis C and/or syphilis
- •11.Condition or disease which could influence the result of the study or which indicates that the patient runs risks by participating in this study
- •12.Participation in any other clinical study, involving other investigational methods or products that may influence the results of this trial, within 30 days prior to participating in this trial
- •1 Patients who responded on the treatment, terminated the treatment at least 3 months prior to the study, and later progressed do not fulfill exclusion criterion 6
- •2 Irradiated lesions are not considered to be measurable and are therefore not suitable as target lesions. Lesions which have been irradiated but shown progression are considered as measurable.
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