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This study compares high-dose interferon alfa-2b treatment with observation in patients with stage II or stage III melanoma. Patients aged 18 and over (10 and over for ECOG patients) with surgically removed melanoma of the skin could take part. The study is in Phase 3; it is not currently recruiting participants but is still ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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