Cognitive Effects of Interferon in Patients With Melanoma

Completed

• Conditions: Melanoma
• Interventions: Biological: Interferon alpha

• Registration Number: NCT02074605
• Lead Sponsor: University of Arizona

Brief Summary

Interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed with high risk malignant melanoma (stage 2 or 3). There is evidence that interferon has some adverse cognitive effects on patients, but there are limited data. The investigators hypothesis is that compared to patients with melanoma who do not receive interferon, patients who have melanoma and are treated with interferon will show an objective decrease in performance on neurocognitive assessment.

This study will enroll patients with melanoma who qualify for interferon, and either decide to undergo interferon treatment or choose watchful waiting instead. All patients will be assessed with a cognitive testing battery twice. Observation patients will undergo testing at their first appointment in which they consent to the study, as well as at their next physician visit, approximately 3 months from the first visit. Interferon patients will be tested immediately prior to starting interferon, as well as immediately after completing high dose interferon.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2014-02
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-26
• Last Update Submitted: 2014-02-26
• Study First Posted: 2014-02-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients diagnosed with high risk malignant melanoma (defined as American Joint Committee on Cancer Stage IIb or greater) electing to undergo treatment with either adjuvant interferon alpha-2b, or observation only.
• Age 18 years or older.
• Karnofsky performance status greater than 60.
• Fluent English speaker.

Exclusion Criteria

• History of neurologic or psychiatric disease that will affect patient's ability to complete protocol tests.
• Clinical or radiological evidence of brain metastasis.
• Any condition, which in the opinion of the investigator makes the subject unsuitable for study participation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interferon alpha	Interferon alpha	Patients who receive high dose interferon alpha for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change in cognitive function	1 month	Cognitive function as assessed by a brief neurocognitive testing battery

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States