EUCTR2010-022103-21-DE进行中（未招募）不适用
eoadjuvant treatment of locoregional metastases in malignant melanoma (AJCC stage IIIB/C) with Multiferon?: a phase IIa DeCOG trial - NAM-Trial
niversity Hospital Tübingen0 个研究点开始时间: 2010年11月19日最近更新:
相关药物
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
- •a)Histologically proven cutaneous melanoma
- •b)Clinical stage IIIB or IIIC (AJCC 2010)
- •c)= 18 years of age
- •d)Presence of at least two metastases, not more than 10 metastases, and completely resectable
- •e)Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with both dimensions >= 5mm
- •f)ECOG performance status of 0/1
- •g)Patients with previous adjuvant recombinant interferon-a 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-a treatment.
- •h)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.
- •i)Signed and dated informed consent informed consent before the start of specific protocol procedures
- •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
- •j)Mucous membrane or ocular melanoma
- •k)Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
- •l)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).
- •m)ALAT or ASAT > 2 x ULN
- •n)Total bilirubin > 2 x ULN
- •o)Creatinine > 2 x ULN
- •p)Patients who have a history of depression requiring hospitalization
- •q)Patients with seizure disorders requiring anticonvulsant therapy
- •r)Any of the following abnormal baseline hematologic/laboratory values:
- •Hb < 10g/dl
- •WBC < 3.0x109 /l
- •Platelets < 100x109 /l
- •s)Presence of active autoimmune disease
- •t)Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
- •u)Unwilling or unable to comply with the requirements of the protocol
- •v)Known infection with HBV, HCV, HIV
- •w)Pregnant or lactating women
- •x)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
研究者
相似试验
已完成
2 期
NAM-Trial: Multiferon in Malignant MelanomaLocoregional Metastases in Malignant Melanoma Stages IIIB/CNCT01341158University Hospital Tuebingen42
进行中（未招募）
不适用
Treatment of locally advanced or metastatic non-small cell lung cancer with Pemetrexed (Alimta) and Gemcitabine or Gemcitabine and Carboplatin: The PAGe study. - The PAGe studyEUCTR2005-001577-97-SEGunnar Hillerdal96
进行中（未招募）
不适用
Chemotherapy for Radically Resected Loco-regional RelapseA randomized clinical trial of adjuvant chemotherapy for radically resectedloco-regional relapse of breast cancerChemotherapy vs. Observation - Chemotherapy for Radically Resected Loco-regional RelapsePatients with radically treated isolated local and/or regional recurrence of invasivebreast cancer after mastectomy or breast-conserving surgery.MedDRA version: 8.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOSEUCTR2005-001484-64-BEInternational Breast Cancer Study Group (IBCSG)265
进行中（未招募）
1 期
Sequential first-line therapy in metastatic colorectal cancer with Capecitabine/FUFA, Irinotecan and Bevacizumabmetastatic colorectal cancerMedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864EUCTR2009-013099-38-DEKlinikum der Universität München, Anstalt des öffentlichen Rechts vertreten durch den Vorstand450
进行中（未招募）
不适用
Dosisdichte 1st-line Therapie des metastasierten Mammakarzinoms mit Paclitaxel und liposomalem Doxorubicin (Myocet®)metastasiertes MammakarzinomMedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancerEUCTR2005-004234-41-DEOtto-von-Guericke Universität Magdeburg