EUCTR2005-002636-97-GB进行中（未招募）不适用
An open-label, phase II study of matured dendritic cells pulsed ex vivo with 3 melanoma cell line lysates (IDD-3) with or without peginterferon alpha-2b (PegIFN-a 2b) in patients with resected stage II or III melanoma
Immuno-Designed Molecules0 个研究点目标入组 50 人开始时间: 2005年7月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •- Age >= 18 years old
- •- Patient with a histologically confirmed stage IIc, IIIb or IIIc primary cutaneous melanoma or unknown primary (AJCC staging). All patients must fulfill one of the criteria below:
- •- Thick (>4.0mm), ulcerated melanoma (stage IIc)
- •- Ulcerated primary melanoma with one or more involved lymph nodes (micro or macro) (T1-4b, N1a/b, N2a/b disease)
- •- Non-ulcerated melanoma with one or more macro lymph node metastasis and/or matted nodes (T1-4a, N1b, N2b disease)
- •- Any satellite/in-transit metastasis with or without lymph node involvement
- •- Nodal recurrence after resection of regional primary melanoma
- •- Nodal recurrence in the basin of a previously complete lymphadenectomy or satellite/in-transit recurrence after previous complete lymphadenectomy
- •- Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first clinically detected nodal or satellite/in-transit recurrence
- •- Patients must have been surgically rendered free of disease with pathologically negative margins on resected specimens.
- •- Patients must be randomized no longer than 56 days (8 weeks) after final surgical resection.
- •- Life expectancy >= 12 months
- •- ECOG performance status 0-1
- •- Women of child bearing potential and fertile men are required to use effective contraception for the duration (negative bHCG for women of child-bearing age)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior therapy with IFN-a or Peg-interferon a
- •- Prior vaccine therapy with one or more melanoma antigens or peptides (with the exception of the GM2 vaccine)
- •- Positive serology (HIV 1 & 2, HTLV-I and II, hepatitis B, hepatitis C, syphilis)
- •- Other significant medical or surgical condition (including history of severe pre existing cardiac disease, chronic renal failure or severe hepatic dysfunction), or any medication or treatment regimens, that would interfere with study participation
- •- Contraindication to apheresis
- •- Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •- Active bacterial, viral or fungal infection within 72 hours of study entry
- •- History of autoimmune disease or immunodeficiency syndrome, except vitiligo
- •- Immunosuppressive treatment within 4 weeks prior to study entry, or anticipated use of immunosuppressives. Inhaled steroid are permitted.
- •- Use of another investigational product within 4 weeks prior to study entry
- •- Pregnant women or nursing women
- •- History of significant psychiatric problems
- •- Epilepsy and/or compromised CNS function
- •- Diabetes milletus or hyperglycemia not effectively treated by medication
- •- Hypersensitivity to PEG-interferon a or any other component of product.
- •- Known hypersensitivity to any of the components of the study drugs (e.g. DMSO)
研究者
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