High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: interferon alfa-2b; observation
Intervention description: Given IV; Patients undergo observation for 4 weeks.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II melanoma; stage III melanoma

Summary:

      RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known
      whether treatment with interferon alfa is more effective than observation alone for stage II
      or stage III melanoma that has been completely removed surgically.

      PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how
      well it works compared to observation only in treating patients with stage II or stage III
      melanoma that has been completely removed by surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed primary melanoma of cutaneous origin

               -  Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)

                    -  Clinically negative regional lymph node pathologic status unknown OR

                    -  Histologically negative regional lymph nodes

               -  Stage III (T4 N0 M0)

                    -  Greater than 4.0 mm Breslow depth OR

               -  Stage III (T1-4 N1)

                    -  One lymph node positive microscopically

          -  Patients must meet at least 1 of the following criteria:

               -  T2b N0 - primary melanoma 1.01-2.0 mm with ulceration, node negative

               -  T3a-b N0 - primary melanoma 2.01-4.0 mm with and without ulceration, node
                  negative

               -  T4a-b N0 - primary melanoma > 4.0 mm with or without ulceration, node negative

               -  T1a N1a-2a (microscopic) - primary melanoma of any thickness with microscopically
                  positive lymph node (any number)

          -  Patients with a positive sentinel node should undergo complete lymphadenectomy of the
             nodal basin prior to study

          -  Must complete all primary therapy (wide excision with or without lymphadenectomy) and
             be randomized in this study within 84 days of wide excision

          -  Must have undergone an adequate wide excision of the primary lesion

          -  Age 18 and over (For ECOG patients only, patients must be >=10 years)

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1

          -  Adequate hematopoietic, hepatic, and renal function based on the following tests:

               -  White blood cell (WBC) cout at least 3,000/mm^3

               -  Platelet count at least 125,000/mm^3

               -  Hematocrit at least 30%

               -  Bilirubin no greater than 2 times upper limit of normal (ULN)

               -  Aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline
                  phosphatase no greater than 2 times ULN

               -  If lactate dehydrogenase or alkaline phosphatase is above normal, a
                  contrast-enhanced computed tomography (CT) scan or Magnetic resonance imaging
                  (MRI) of the liver is required to document the absence of tumor

               -  Blood urea nitrogen (BUN) no greater than 33 mg/dL OR Creatinine no greater than
                  1.8 mg/dL

          -  No other concurrent or prior malignancies within the past 5 years except:

               -  Cancer in situ

               -  Lobular carcinoma in situ of the breast

               -  Carcinoma in situ of the cervix

               -  Atypical melanocytic hyperplasia or Clark 1 melanoma in situ

               -  Basal or squamous cell skin cancer

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after study

        Exclusion Criteria:

          -  Clinical, radiological/laboratory, or pathological evidence of incompletely resected
             melanoma or any distant metastatic disease

          -  Clinically palpable lymphadenopathy

          -  Evidence of organic brain syndrome or significant impairment of basal cognitive
             function or any psychiatric disorder that would preclude study participation

          -  Other significant medical or surgical condition, or any medication or treatment
             regimens, that would interfere with study participation

          -  Pregnant or nursing

          -  Other history of invasive melanoma

          -  Autoimmune disorders or conditions of immunosuppression

          -  History of active ischemic heart disease

          -  Cerebrovascular disease

          -  Congestive heart failure (New York Heart Association class III or IV heart disease)

          -  Prior or concurrent chemotherapy

          -  Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or
             other biologic response modifiers for melanoma

          -  Concurrent systemic corticosteroids including oral steroids (i.e., prednisone,
             dexamethasone), topical steroid creams or ointments, or any steroid-containing
             inhalers

          -  Prior or concurrent radiotherapy

          -  Other concurrent immunosuppressive medications