Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

This study is ongoing, but not recruiting participants.
Dermatologic Cooperative Oncology Group
Information provided by (Responsible Party):
Thomas Eigentler, University Hospital Tuebingen Identifier:
First received: September 12, 2005
Last updated: January 28, 2014
Last verified: January 2014

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
Drug: pegylated interferon-alpha-2a
Drug: interferon-alpha-2a
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Time to distant metastasis

Secondary Outcome Measures:
  • Disease free survival at 5 years
  • Overall survival at 5 years
  • Quality of life
  • Tolerability

Estimated Enrollment: 880
Study Start Date: October 2004
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PegIFN
pegylated interferon-alpha-2a
Drug: pegylated interferon-alpha-2a
Active Comparator: IFN
Drug: interferon-alpha-2a


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven cutaneous melanoma
  • ≥ 18 years of age and < 75 years of age
  • Have confirmed stage IIa (T3a), IIB, IIC, IIIA or IIIB (AJCC 2002) melanoma (lymph node staging either per sentinel node biopsy or elective lymph node dissection)
  • Have a Karnofsky performance status of ≥ 80%
  • Negative pregnancy test
  • Start of therapy within three months after surgery
  • Informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
  • Mucous membrane or ocular melanoma
  • Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening)
  • Patients who have received chemotherapy or vaccines for melanoma
  • Patients with tumor progression under a previous adjuvant interferon therapy or within three months after termination of interferon therapy (patients previously receiving adjuvant interferon therapy in another tumor stage without disease progression may be included)
  • History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix)
  • Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
  • ALAT or ASAT > 2 x ULN
  • Bilirubin > 2 x ULN
  • Creatinine > 2 x ULN
  • Patients who have a history of depression or other psychiatric diseases requiring hospitalisation
  • Patients with seizure disorders requiring anticonvulsant therapy
  • Any of the following abnormal baseline hematologic/laboratory values:

    • Hb <10g/dl
    • WBC <3.0 x 109 /l
    • Platelets <100x109/l
    • Neutrophils < 1.5 x 109/l
  • History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes)
  • Unwilling or unable to comply with the requirements of the protocol for the duration of the study
  • Known infection with HBV, HCV, HIV
  • Evidence of allergy or hypersensitivity against IFN or pegylated interferon
  • Thyroid disease poorly controlled on prescribed medications
  • Systemic corticosteroid therapy for any reason (>1 month)
  Contacts and Locations
Please refer to this study by its identifier: NCT00204529

Arbeitsgemeinschaft Dermatologische Onkologie, Skin Cancer Program, Department of Dermatology, University of Tübingen
Tübingen, BW, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Dermatologic Cooperative Oncology Group
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
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Eigentler, MD, University Hospital Tuebingen Identifier: NCT00204529     History of Changes
Other Study ID Numbers: ML17840
Study First Received: September 12, 2005
Last Updated: January 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
malignant melanoma
adjuvant therapy
Adjuvants, Immunologic

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adjuvants, Immunologic
Interferon Alfa-2a
Peginterferon alfa-2a
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 20, 2014