A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Pegylated Interferon Alfa-2b; Pegylated Interferon Alfa-2b
Intervention description: 6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks; 3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant
      treatment for melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Competent to self-administer the subcutaneous injections of PEG-IFN

          -  Histologically documented involved regional lymph nodes of a primary cutaneous
             melanoma or unknown primary, meeting the study's staging criteria

          -  Had the primary melanoma completely resected with adequate surgical margins and
             undergone operation for positive regional lymph nodes within 84 days of study start

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1

          -  Adequate hepatic, renal and bone marrow function as defined by study parameters
             obtained within 4 weeks prior to study start

          -  For a female subject who is of childbearing potential or male participant with female
             sexual partner who is of childbearing potential, agree to use acceptable methods of
             contraception for at least 2 weeks prior to study start and continue until at least 6
             months after last dose of study medication, or longer if dictated by local regulations

        Exclusion Criteria:

          -  Mucous membrane melanoma or ocular melanoma

          -  Known hypersensitivity to the components of study drug (including acetaminophen), or
             its analogs

          -  Evidence of distant or non-regional lymph node metastases or in-transit metastases

          -  Disease that cannot be completely surgically resected

          -  Prior malignancy within the past 5 years other than surgically cured non-melanoma skin
             cancer or cervical carcinoma in situ

          -  Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment,
             congestive heart failure or symptomatic ischemic heart disease

          -  Hepatic decompensation

          -  Thyroid dysfunction not responsive to therapy

          -  Uncontrolled diabetes mellitus

          -  Clinically active autoimmune disease

          -  Clinically active and/or uncontrolled infection, including active hepatitis

          -  Human immunodeficiency virus (HIV)

          -  History of neuropsychiatric disorder requiring hospitalization

          -  Actively abusing alcohol or drugs

          -  Pregnant, lactating, or of reproductive potential and not using an effective means of
             contraception

          -  Medical condition requiring chronic systemic corticosteroids

          -  Received any experimental therapy within 30 days prior to enrolling in this study

          -  Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for
             melanoma

          -  Previously received interferon-α for any reason

          -  Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b