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 sites12 target enrollmentSeptember 7, 2011

ConditionsPreviously treated metastatic melanoma in stage IV or III unresectable MedDRA version: 14.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsCialis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Previously treated metastatic melanoma in stage IV or III unresectable
Sponsor: Ruprecht-Karls-University Heidelberg, Med Faculty represented by Universitätsklinikum Heidelberg and its Commercial D
Enrollment: 12
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 7, 2011

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ruprecht-Karls-University Heidelberg, Med Faculty represented by Universitätsklinikum Heidelberg and its Commercial D

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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