EUCTR2011-003273-28-DE进行中（未招募）不适用
Treatment of patients with metastatic melanoma (AJCC stage IV or III unresectable) with the PDE-inhibitor Tadalafil:A Pilot Trial for Proof of Principle” - TaMe-Trial
Ruprecht-Karls-University Heidelberg, Med Faculty represented by Universitätsklinikum Heidelberg and its Commercial D0 个研究点目标入组 12 人开始时间: 2011年9月7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
- 12
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 metastatic melanoma
- •b)Clinical stage IV or III unresectable (AJCC 2010)
- •c)= 18 to 75 years of age
- •d)Presence of cutaneous or accessible lymph node metastases (tumor biopsies)
- •e)Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with at least one diameter = 5 mm and the other dimension = 5 mm assessed by ultrasound)
- •f)ECOG performance status of 0-2
- •g)At least one prior treatment for metastatic disease.
- •h)No medical contraindication to biopsy of target lesion.
- •i)Willingness and ability to give signed written informed consent.
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •j)Any evidence of brain metastases
- •k)Patients with severe cardiac disease (e.g. NYHA Functional Class II, III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris, sinusbradycardia).
- •l)Concurrent medication with nitrates
- •m)Uncontrolled blood pressure (<90/50mm Hg or uncontrolled hypertone)
- •n)laboratory data (to be obtained within 4 weeks of initiation):
- •Platelets < 75,000/mm³
- •Calculated Creatinine Clearance (CRCL) < 60 ml/min
- •ALAT or ASAT > 2 x ULN
- •Total serum bilirubin > 1.5 mg/dl
- •o)Patients who have a history of depression requiring hospitalization
- •p)Patients with seizure disorders requiring anticonvulsant therapy
- •q)Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
- •r)History of ischemic neuropathy of the optical nerve (NAION)
- •s)Brain insult within the last 6 months
- •t)Anatomic penis deformation or history of priapismus or predisposing illness like sickle cell anemia or hyperglobulinaemia
- •u)Patients with a history of a curatively treated malignancy must be disease-free and have a survival prognosis that exceeds five years.
- •v)Unwilling or unable to comply with the requirements of the protocol
- •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
尚未招募
2 期
Treatment of patients with metastatic melanoma (AJCC stage IV or III unresectable) with the PDE-inhibitor Tadalafil:A Pilot Trial for Proof of Principle”DRKS00003495niversitätsklinikum Heidelberg12
Unknown
2 期
Treatment of Metastatic Melanoma With Tumor Infiltrating Lymphocytes and IL-2 Following Lympho-depleting ChemotherapyMetastatic MelanomaNCT00604136Hadassah Medical Organization20
已完成
2 期
Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic MelanomaNeoplasm MetastasisMelanomaNCT00001832National Cancer Institute (NCI)170
已完成
2 期
Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat MelanomaMetastatic MelanomaSkin CancerNCT00665470National Cancer Institute (NCI)10
已完成
不适用
Metastatic Melanoma Patients Under Immunotherapy: Monitoring of Therapeutic Success Using Liquid Biopsy and PET/CT in a Prospective StudyC43Malignant melanoma of skinDRKS00017724niversitäts-Hautklinik Tübingen100