Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon - Full Text View

Sponsored by:	Dermatologic Cooperative Oncology Group
Information provided by:	Dermatologic Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00226408

Purpose

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.

Condition	Intervention	Phase
Adjuvant Stage III Malignant Melanoma Interferon Alpha Therapy	Drug: Interferon-alpha-2b	Phase III

MedlinePlus related topics: Melanoma

Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Multicenter Study for Adjuvant Treatment of Stage III Malignant Melanoma: Intermittent, High-Dose Intravenous Interferon Alpha-2b Versus Standard High-Dose Interferon Alpha-2b Therapy

Further study details as provided by Dermatologic Cooperative Oncology Group:

Primary Outcome Measures:

distant metastasis free survival/(DMFI )

Secondary Outcome Measures:

overall survival
time to progression
toxicity

Estimated Enrollment:	600
Study Start Date:	November 2003
Estimated Study Completion Date:	September 2005

Detailed Description:

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226408

Contacts

Contact: Peter Mohr, MD	0049 41261 703 ext 6207	p.mohr@elbekliniken.de
Contact: Michael Weichenthal, MD	0049 431 597 ext 1537	mweichenthal@dermatology.uni-kiel.de

Locations

Germany
Elbekliniken Buxtehude	Recruiting
Buxtehude, Germany, 21614
Contact: Peter Miohr, MD 0049 4161 703 ext 6207 p.mohr@elbekliniken.de
Contact: michael weichenthal, MD 0049 431 597 ext 1537 mweichenthal@dermatolgy.uni-kiel.de
Universitätsklinikum des Saarlandes, Hautklinik	Recruiting
Homburg/ Saar, Germany, 66421
Contact: Wolfgang Tilgen, MD 0049/6841-162 ext 3966
Praxis	Recruiting
Hannover, Germany, 30159
Contact: Peter von Wussow, MD 0049/511 ext 3069998
universitätsklinikum Münster	Recruiting
Münster, Germany, 48149
Contact: T. Luger, MD 0049/25183 ext 56501
Christian- Albrechts- Universität ,Hautklinik	Recruiting
Kiel, Germany, 24105
Contact: Axel Hauschild, MD 0049/431-597 ext 15
Universitätshautklinik ,St.Josef- Hospital	Recruiting
Bochum, Germany, 44791
Contact: Norbert Brockmeyer, MD 0049/234 ext 509-1
Universitätshautklinik Köln	Recruiting
Köln, Germany, 50931
Contact: Cornelia Mauch, MD 0049/221478 ext 537
Universitätshautklinik Mainz	Recruiting
Mainz, Germany, 55131
Contact: Kerstin Steinbrink, MD 0049/61311771 ext 30
Universitätshautklinik Heidelberg	Recruiting
Heidelberg, Germany, 69115
Contact: Alexander Enk, MD
Universitätshautklinik Essen	Recruiting
Essen, Germany, 45122
Contact: Carmen Loquai, MD 0049/201-723 ext 243
Städtische Kliniken Oldenburg	Recruiting
Oldenburg, Germany, 261333
Contact: Erhard Hölzle, MD
Universitätshautklinik Ulm	Recruiting
Ulm, Germany, 89081
Contact: Cord Sunderkötter, MD
Universitätsklinik Eppendorf	Recruiting
Hamburg, Germany, 20246
Contact: Karsten Neuber, MD 0049/42803 ext 2632

Sponsors and Collaborators

Dermatologic Cooperative Oncology Group

Investigators

Principal Investigator:	Peter Mohr, MD	Elbeklinikum, Buxtehude, Germany
Principal Investigator:	Peter von Wussow, MD	30159 Hannover,Georgstr.46

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	MM-ADJ-5
Study First Received:	September 25, 2005
Last Updated:	June 20, 2006
ClinicalTrials.gov Identifier:	NCT00226408
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dermatologic Cooperative Oncology Group:

melanoma,adjuvant therapy,stageIII Interferon
high dose

Study placed in the following topic categories:

Interferon-alpha
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Interferons
Neuroepithelioma

Nevus
Interferon Alfa-2a
Interferon Alfa-2b
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antiviral Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009