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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: pegylated interferon-alpha-2a
• Drug: interferon-alpha-2a

Primary Measures

• Time to distant metastasis

Secondary Measures

• Disease free survival at 5 years
• Overall survival at 5 years
• Quality of life
• Tolerability

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 ad-juvant 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 tachyarrythmias 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital Tuebingen

Overall Clinical Trial Officials and Contacts

Claus Garbe, MD Principal Investigator Skin Cancer Program, Department of Dermatology, University of Tübingen, Liebermeisterstr. 20, 72076 Tübingen, Germany  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00204529

Study ID Number: ML17840

ClinicalTrials.gov Identifier: NCT00204529

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Synposis of study protocoll