Clinical Trial 18686

Cancer Type: Cutaneous
Interventions:PEG-Intron (Peginterferon Alfa 2B); interferon alfa

Study Type: Other
Phase of Study: Phase IV
Investigators:

  • Nikhil Khushalani

Overview

Study Title

An Observational Pilot Study to Compare the Compliance with and Health Related Quality of Life during Therapy with Standard High-Dose Interferon Alfa (Intron® A, HDI) versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) in Patients with Surgically Resected Melanoma

Summary

The purpose of this study is to evaluate patient cooperation and impression of treatment, as well as to assess the health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing standard High-Dose Interferon Alfa (Intron® A, HDI) versus Pegylated Alfa-Interferon 2b (Sylatron, PEG IFN) therapy.

Objective

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 patient's 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

  • Man or woman at least 18 years of age
  • Has had surgically resected melanoma and plans to receive adjuvant therapy with HDI or PEG IFN
  • Willing and able to give written informed consent
  • Willing to comply with all study requirements
  • Female participants and male participants with female partners of child bearing potential must use adequate contraceptive measures while on treatment.

  • Exclusion Criteria

  • Unable or unwilling to complete quality of life (QoL) or compliance questionnaires
  • A history of anaphylaxis due to any interferon alpha product
  • Has autoimmune hepatitis
  • Has decompensated liver disease (Child-Pugh score >6 [Class B and C])
  • Has a history of any 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 (e.g., disorders that have required past hospitalization).
  • Patients with uncontrolled cardiac disease or a history of a confirmed myocardial infarction within the last 6 months, uncontrolled diabetes mellitus, uncontrolled hyper or hypothyroidism and significant autoimmune disease requiring steroid therapy.