Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Melanoma

Ulcer

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon alpha-2

Antiviral Agents

PEG IFN alfa-2b

Alexander Eggermont, MD, PHD

Patients with an ulcerated melanoma with Breslow \>1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk.

The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.

Adjuvant PEG Intron in Ulcerated Melanoma

Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.

This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.

NCIC Clinical Trials Group

European Organisation for Research and Treatment of Cancer - EORTC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant PEG Intron in Ulcerated Melanoma	NCT01502696	Ulcerated Melan...	PEG IFN alfa-2b	18 Years - 70 Years	European Organisation for Research and Treatment of Cancer - EORTC
Adjuvant PEG Intron in Ulcerated Melanoma	NCT01502696	Ulcerated Melan...	PEG IFN alfa-2b	18 Years - 70 Years	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for ulcerated primary cutaneous melanoma