Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 to 70	Other	MM-ADJ-5 NCT00226408

Trial Description

Summary

The study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival (DMFI) as a primary endpoint.

Further Study Information

Arm A: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v followed by 48 weeks of treatment with 3 x 10 MIU/m2 s.c Arm B: Interferon-alpha-2b 20 MIU/m2 for 4 weeks. 5 days a week i.v repeated 3 times with 12 treatment-free-weeks between the cycles

Secondary endpoints: Improved overall survival rate, Assess side effects of therapy in both treatment arms, Assess time spent on sick leave, Assess number of treatment-related days in hospital, Assess overall performance status, Assess blood MX protein levels

Eligibility Criteria

Inclusion Criteria:

• Histological documentet cutaneous malognant melanoma

• Stage IIIa, IIIb, IIIc (AJCC 2002)

• R0 resection dating back no longer than 56 days

• Performance status (ECOG o-1)

• Bone marrow funktion: White cell count > 3000 cells/ul, platletts > 100000 cells/ul, hemoglobin > 10 g/dl

• Liver and kidney funktion: Serum creatinin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal, Serum bilirubin < 2 times upper limit of normal

• Written inform consent

Exclusion Criteria:

• Confirmed distant metastasis

• Choroid or mucosal melanoma

• Pregnant or lactating women and women of childbearing potential not using a reliable form of contraception

• Active autoimmun disease

• patients with history of neuropsychiatric disease requiring hospitalization

• Severe medical condition such us:

• Florid hepatitis

• Severe acute infection

• Myocardial infarction within the past year,symptomatic angina pectoris

• Grade III to IV congestive heart failure

• serious pulmonary disease

• HIV-positive patients with an AIDS - defining condition

• treatment in another clinical drug trial within the last 30 days

• A history of hypersensitivity to interferon alfa

• History of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma)

• Prior high dose interferon alfa therapy.Prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

Dermatologic Cooperative Oncology Group

Peter Mohr, MD

Principal Investigator

Peter von Wussow, MD

Principal Investigator

Peter Mohr, MD		Ph: 0049 41261 703 Ext.6207
		Email: p.mohr@elbekliniken.de

Michael Weichenthal, MD		Ph: 0049 431 597 Ext.1537
		Email: mweichenthal@dermatology.uni-kiel.de

Germany
	Bochum
	St. Josef-Hospital - Bochum
		Norbert Brockmeyer, MD	Ph: 0049/234 Ext.509-1
	Buxtehude
	Elbe Kliniken Buxtehude
		Peter Miohr, MD	Ph: 0049 4161 703 Ext.6207
			Email: p.mohr@elbekliniken.de
		michael weichenthal, MD	Ph: 0049 431 597 Ext.1537
			Email: mweichenthal@dermatolgy.uni-kiel.de
	Essen
	Universitaetsklinikum Essen
		Carmen Loquai, MD	Ph: 0049/201-723 Ext.243
	Hamburg
	University Medical Center Hamburg - Eppendorf
		Karsten Neuber, MD	Ph: 0049/42803 Ext.2632
	Hannover
	Praxis
		Peter von Wussow, MD	Ph: 0049/511 Ext.3069998
	Heidelberg
	Universitaets-Hautklinik Heidelberg
		Alexander Enk, MD
	Homburg/ Saar
	Universitaetsklinikum des Saarlandes
		Wolfgang Tilgen, MD	Ph: 0049/6841-162 Ext.3966
	Kiel
	Christian- Albrechts- Universität ,Hautklinik
		Axel Hauschild, MD	Ph: 0049/431-597 Ext.15
	Köln
	Medizinische Universitaetsklinik I at the University of Cologne
		Cornelia Mauch, MD	Ph: 0049/221478 Ext.537
	Mainz
	Johannes Gutenberg University
		Kerstin Steinbrink, MD	Ph: 0049/61311771 Ext.30
	Münster
	Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
		T. Luger, MD	Ph: 0049/25183 Ext.56501
	Oldenburg
	Klinikum Oldenburg
		Erhard Hölzle, MD
	Ulm
	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
		Cord Sunderkötter, MD

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00226408
Information obtained from ClinicalTrials.gov on March 18, 2009