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Sponsors and Collaborators: |
University Hospital Tuebingen Dermatologic Cooperative Oncology Group |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00204529 |
The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB.
A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.
Condition | Intervention | Phase |
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Melanoma |
Drug: pegylated interferon-alpha-2a Drug: interferon-alpha-2a |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Multicenter, Open Label Study to Compare the Efficacy and Tolerability of Pegylated Interferon-Alpha-2 (PEG-IFN) to 'Low-Dose' Interferon-Alpha-2a in Patients With Malignant Melanoma in Stages IIA (T3a) - IIIB (AJCC 2002) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following abnormal baseline hematologic/laboratory values:
Germany, BW | |
Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen | |
Tübingen, BW, Germany, 72076 |
Principal Investigator: | Claus Garbe, MD | Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany |
Principal Investigator: | Hubert Pehamberger, MD | Department of Dermatology, University Hospital Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria |
Study ID Numbers: | ML17840 |
Study First Received: | September 12, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00204529 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
malignant melanoma adjuvant therapy Adjuvants, Immunologic |
Interferon-alpha Neuroectodermal Tumors Interferon Type I, Recombinant Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Interferons |
Peginterferon alfa-2a Neuroepithelioma Nevus Interferon Alfa-2a Neuroendocrine Tumors Melanoma |
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 |