Last updated on June 2006

Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon


Brief description of study

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.

Detailed Study 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

Clinical Study Identifier: NCT00226408

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Norbert Brockmeyer, MD

Universit tshautklinik ,St.Josef- Hospital
Bochum, Germany
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Peter Miohr, MD

Elbekliniken Buxtehude
Buxtehude, Germany
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Carmen Loquai, MD

Universit tshautklinik Essen
Essen, Germany
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Karsten Neuber, MD

Universit tsklinik Eppendorf
Hamburg, Germany
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Peter von Wussow, MD

Praxis
Hannover, Germany
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Alexander Enk, MD

Universit tshautklinik Heidelberg
Heidelberg, Germany
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Wolfgang Tilgen, MD

Universit tsklinikum des Saarlandes, Hautklinik
Homburg/ Saar, Germany
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Axel Hauschild, MD

Christian- Albrechts- Universit t ,Hautklinik
Kiel, Germany
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Cornelia Mauch, MD

Universit tshautklinik K ln
Köln, Germany
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Kerstin Steinbrink, MD

Universit tshautklinik Mainz
Mainz, Germany
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T. Luger, MD

universit tsklinikum M nster
Münster, Germany
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Erhard Hölzle, MD

St dtische Kliniken Oldenburg
Oldenburg, Germany
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Cord Sunderkötter, MD

Universit tshautklinik Ulm
Ulm, Germany
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