NCT01341158已完成2 期
Neoadjuvant Treatment of Locoregional Metastases in Malignant Melanoma (AJCC Stage IIIB/C) With Multiferon: a Phase IIa DeCOG Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The current clinical trial shall clarify the efficacy, safety and biologic effects of neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional metastases of melanoma in stage IIIB/C.
详细描述
The study is an open label, multicenter phase IIa clinical trial which is designed as a pilot project in order to establish the efficacy and tolerability of Multiferon as a neoadjuvant treatment of locoregional metastases. Patients will be treated subsequently in cohorts characterized by different doses (3 - 9 - 18 MIU) to analyze dosage dependent effects.
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 proven cutaneous melanoma
- •Clinical stage IIIB or IIIC (AJCC 2010)
- •≥ 18 years of age
- •Presence of at least two metastases, not more than 10 metastases, and completely resectable
- •Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with both dimensions at least 10 mm x 10 mm for spiral CT and 5 mm x 5 mm for locoregional metastases assessed by ultrasound or digital photography)
- •ECOG performance status of 0/1
- •Patients with previous adjuvant recombinant interferon-α treatment of any dose are eligible if (i) treatment was stopped at least 1 month before start of treatment and (ii) no progression occurred during interferon-α treatment.
- •No childbearing potential or negative pregnancy test within 14 days before inclusion in women with child bearing potential Women with childbearing potential must be using an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, spermicides]) throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
- •No men of fathering potential or men of fathering potential must be using an effective method of contraception to avoid conception throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
- •Signed and dated informed consent informed consent before the start of specific protocol procedures
排除标准
- •Mucous membrane or ocular melanoma
- •Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
- •Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris).
- •ALAT or ASAT > 2 x ULN
- •Total bilirubin > 2 x ULN
- •Creatinine > 2 x ULN
- •Evidence or history of depression. If this condition can not be ruled out, the patient should be transferred to a psychiatrist for consultation and further assessment before inclusion.
- •Patients with seizure disorders requiring anticonvulsant therapy
- •Any of the following abnormal baseline hematologic/laboratory values:
- •Hb < 10g/dl WBC < 3.0x109 /l Platelets < 100x109 /l
- •Presence of active autoimmune disease
- •Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
- •Unwilling or unable to comply with the requirements of the protocol
- •Known infection with HBV, HCV, HIV
- •Pregnant or lactating women
- •Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
- •Known or suspected allergy to human interferon alpha or any ingredient of the IMP.
- •Any thyroid dysfunctions not responsive to therapy
- •Presence of chronic hepatitis with decompensated liver cirrhosis
- •Immunosuppression in patients with transplantation
- •Evidence or history of bleeding diathesis or coagulopathy
研究组 & 干预措施
Experimental arm
Experimental
干预措施: human interferon-α (Drug)
结局指标
主要结局
Overall response rate
时间窗: after 4 weeks of treatment
Overall response rate (clinical and radiological) after 4 weeks of treatment (CR + PR) according to immune-related response criteria (irRC)
次要结局
- Rate of histopathological complete responses(after 4 weeks of treatment)
- Tolerability(after 4 weeks of treatment)
- Disease control rate(after 4 weeks of treatment)
- Differences in gene expression in metastatic tissue before/after treatment(after 4 weeks of treatment)
- Changes of serum markers and PBMC subsets before/after treatment (optional translational side studies)(after 4 weeks of treatment)
- Dose dependency of effects(after 4 weeks of treatment)
研究者
Benjamin Weide, M.D.
Dr. Benjamin Weide
University Hospital Tuebingen
研究点 (1)
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