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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Melanoma

Intervention / Treatment
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* Drug: pegylated interferon-alpha-2a
* Drug: interferon-alpha-2a


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PegIFN<br>pegylated interferon-alpha-2a | Drug: pegylated interferon-alpha-2a<br> <br> |
| Active Comparator: IFN<br>interferon-alpha-2a | Drug: interferon-alpha-2a<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to distant metastasis |  | From date of randomization until the date of first documented distant metastases or date of death from any cause, whichever came first, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 5 years | 
| Overall survival |  | 5 years | 
| Quality of life |  | Measured at different visits (week 0, week 12, month 3, month 6) | 
| Number and Grade of Adverse Events |  | Measured at every visit (week 4, week 8, week 12, month 3, month 6 and every 3 months during therapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant melanoma, adjuvant therapy, Adjuvants, Immunologic