Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon
NCT ID: NCT00226408
Last Updated: 2006-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
600 participants
INTERVENTIONAL
2003-11-30
2005-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Interferon-alpha-2b
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Dermatologic Cooperative Oncology Group
OTHER
Principal Investigators
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Peter Mohr, MD
Role: PRINCIPAL_INVESTIGATOR
Elbeklinikum, Buxtehude, Germany
Peter von Wussow, MD
Role: PRINCIPAL_INVESTIGATOR
30159 Hannover,Georgstr.46
Locations
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Universitätshautklinik ,St.Josef- Hospital
Bochum, , Germany
Elbekliniken Buxtehude
Buxtehude, , Germany
Universitätshautklinik Köln
Cologne, , Germany
Universitätshautklinik Essen
Essen, , Germany
Universitätsklinik Eppendorf
Hamburg, , Germany
Praxis
Hanover, , Germany
Universitätshautklinik Heidelberg
Heidelberg, , Germany
Universitätsklinikum des Saarlandes, Hautklinik
Homburg/ Saar, , Germany
Christian- Albrechts- Universität ,Hautklinik
Kiel, , Germany
Universitätshautklinik Mainz
Mainz, , Germany
universitätsklinikum Münster
Münster, , Germany
Städtische Kliniken Oldenburg
Oldenburg, , Germany
Universitätshautklinik Ulm
Ulm, , Germany
Countries
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Central Contacts
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Facility Contacts
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Norbert Brockmeyer, MD
Role: primary
Cornelia Mauch, MD
Role: primary
Carmen Loquai, MD
Role: primary
Karsten Neuber, MD
Role: primary
Peter von Wussow, MD
Role: primary
Alexander Enk, MD
Role: primary
Wolfgang Tilgen, MD
Role: primary
Axel Hauschild, MD
Role: primary
Kerstin Steinbrink, MD
Role: primary
T. Luger, MD
Role: primary
Erhard Hölzle, MD
Role: primary
Cord Sunderkötter, MD
Role: primary
References
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Mohr P, Hauschild A, Trefzer U, Enk A, Tilgen W, Loquai C, Gogas H, Haalck T, Koller J, Dummer R, Gutzmer R, Brockmeyer N, Holzle E, Sunderkotter C, Mauch C, Stein A, Schneider LA, Podda M, Goppner D, Schadendorf D, Weichenthal M. Intermittent High-Dose Intravenous Interferon Alfa-2b for Adjuvant Treatment of Stage III Melanoma: Final Analysis of a Randomized Phase III Dermatologic Cooperative Oncology Group Trial. J Clin Oncol. 2015 Dec 1;33(34):4077-84. doi: 10.1200/JCO.2014.59.6932. Epub 2015 Oct 26.
Related Links
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Related Info
Other Identifiers
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MM-ADJ-5
Identifier Type: -
Identifier Source: org_study_id