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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dermatologic Cooperative Oncology Group
Information provided by (Responsible Party):
Thomas Eigentler, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204529
First received: September 12, 2005
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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
Melanoma
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
interferon-alpha-2a
Drug: interferon-alpha-2a

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00204529

Locations
Germany
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
Investigators
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
ClinicalTrials.gov 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:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adjuvants, Immunologic
Interferon-alpha
Interferon Alfa-2a
Interferons
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

ClinicalTrials.gov processed this record on April 20, 2014