A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma

The primary objective of this study is:

• To evaluate compliance with the administration of standard HDI versus PEG IFN for patients
with melanoma in need of adjuvant therapy

The secondary objectives of this study are:

- To compare the convenience and satisfaction with chemotherapy for patients on standard
HDI versus PEG IFN using a chemotherapy convenience and satisfaction questionnaire
(CCSQ) and to evaluate the treatment-related side effects that may impact the patient's
HRQOL using the Functional Assessment of Cancer Therapy of Biologic Response Modifier
(FACT BRM)

- To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer
Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on
standard HDI versus PEG IFN

- To examine reasons for patients' choice of treatment with HDI versus PEG IFN, for those
cases in which patients are presented with a choice of either treatment option

- To assess Health Resource Utilization on both arms of the study

Inclusion Criteria:

- Patient is male or female at least 18 years of age

- Patient has had surgically resected melanoma and plans to receive adjuvant therapy
with HDI or PEG IFN

- Patient is willing and able to give written informed consent

- Patient is willing to comply with all study requirements

Exclusion Criteria:

- Patient is unable or unwilling to complete QoL questionaire or compliance diary

- Patient has a history of anaphylaxis due to any interferon alpha product

- Patient has autoimmune hepatitis

- Patient has decompensated liver disease (Child-Pugh score>6 ( Class B and C)

- Patient has a history of neuropsychiatric disorder (including depression) that, in the
judgment of the investigator, may impair the patient's ability to successfully
complete treatment or protocol-related requirements