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

niversitätsklinikum Heidelberg0 sites12 target enrollmentJanuary 27, 2012

Overview

No summary available.

Registry

who.int

Start Date

January 27, 2012

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversitätsklinikum Heidelberg

•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, including established treatments like Ipilimumab.
•h) No medical contraindication to biopsy of target lesion.
•i) Willingness and ability to understand the informed consent and the quality of life questionnaires and to give signed written informed consent.
•j) Women of childbearing potential must agree to use effective contraception during the study.

•a) Any evidence of brain metastases
•b) 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).
•c) Concurrent medication with nitrates, alpha\-Blockers e.g. Doxazosin or other interacting medications (CYP3A4 inhibitors e.g. Ketoconazole, Erythromycin, Clarithromycin, Intraconazol and grape fruit juice, CYP3A4 inductors e.g. Rifampicin, Phenobarbital, Phenytoin and Carbamazepin)
•d) Uncontrolled blood pressure (\<90/50mm Hg or uncontrolled hypertone)
•e) 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
•f) Patients who have a history of depression requiring hospitalization