| Exclusion Criteria: | 1) Female subjects who are pregnant, intend to become pregnant, or are breastfeeding.
2) Subjects previously treated with interferon alpha, chemotherapy, or immunotherapy for melanoma.
3) Subjects with ocular melanoma, or melanoma of the mucous membranes.
4) Subjects who have evidence of distant or non-regional lymph node metastases.
5) Subjects with in-transit melanoma (ie, TsubscriptanyNsubscript2c,subscript3 Msubscript0) at study entry are not eligible, even if the lesion has been resected
6) Subjects whose disease cannot be completely surgically resected, because of extensive extracapsular extension.
7) Subjects who have not recovered from the effects of recent surgery.
8) Subjects with a history of prior malignancy within the past 5 years other than surgically cured squamous cell carcinoma of the skin,successfully resected early stage cutaneous melanoma (ie, Tsubscript0, Tsubscript1, Tsubscript2A ), or cervical carcinoma in situ.
9) Subjects who have severe cardiovascular disease, ie, arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease.
10) Subjects with thyroid dysfunction not responsive to therapy.
11) Subjects who, in the opinion of the investigator, have uncontrolled diabetes mellitus.
12) Subjects suffering from an active autoimmune disease.
13) Subjects with active and/or uncontrolled infection, including active hepatitis.
14) Subjects who have a history of seropositivity for HIV.
15) Subjects with pre-existing psychiatric condition, including but not limited to: a. History of severe depression including the following 1) Hospitalization for depression 2) Electroconvulsive therapy for depression 3) Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions b. Suicidal or homicidal ideation and/or suicidal or homicidal attempt c. History of severe psychiatric disorders (eg, psychosis, post-traumatic stress disorder or mania) d. Past history or current use of lithium and/or antipsychotic drugs
16) Subjects with a clinical diagnosis of substance abuse of the one or more of the following drugs, within the following timeframes, (not including time spent in detoxification, hospitalization or incarceration): a. Alcohol, intravenous drug use (IVDU), inhalational, psychotropics, narcotics, cocaine, prescription or over-the-counter drugs: within 1 year of the Screening visit.
17) #17 Contd. b. Subjects receiving methadone, buprenorphine HCL, and/or butorphanol tartrate within 1 year of Screening visit, unless subject has drug screen negative for other (non-narcotic) drugs documented in past year and repeated negative within 2 months of Screening visit. c. Multi-drug abuse (2 or more substances): within 3 years of Screening visit.
18) #17 Contd. d.If the subject's historic marijuana use is deemed excessive by the principal investigator (or medically qualified individual) or is interfering with the subject's life, then the subject is not eligible and should not be screened. If subject's marijuana use is not deemed excessive by PI and does not interfere with life, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into study.
19) Subjects with a medical condition requiring chronic systemic corticosteroids.
20) Subjects known to be allergic to the drug substance or any of the excipients in the PEG-Intron formulation.
21) Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
22) Subjects who have used any investigational drugs within 30 days of study entry.
23) Subjects who are participating in any other clinical studies of investigational treatments. |