Cognitive Effects of Interferon in Patients With Melanoma

Melanoma Clinical Trial

Official title:

A Pilot Study of Neurocognitive Function in Patients Treated With Adjuvant Interferon Alpha-2b for High-Risk Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074605
• Other study ID #: 08-0389-02
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: February 26, 2014
• Start date: July 2008
• Est. completion date: May 2010

Study information

• Verified date: February 2014
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Interferon alpha

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (2)

Combs D, Baker A, Herring A, Trevor K, Jeter J, Cranmer L. Effects of high dose interferon on memory in melanoma patients. Pigment Cell and Melanoma Research 22(6):866, Dec 2009. Abstract.

Combs D, Baker A, Jordan S, Morgan S, Pestana L, Herring A, Jeter J, Hersh E, Cranmer LD. Screening tools for interferon-related cognitive decline in melanoma patients. J Clin Oncol 28:7s, May 2010 (suppl; abstr 8539). Abstract.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive function	Cognitive function as assessed by a brief neurocognitive testing battery	1 month	No