Clinical trial NCT02074605: Cognitive Effects of Interferon in Patients With Melanoma
Official title: A Pilot Study of Neurocognitive Function in Patients Treated With Adjuvant Interferon Alpha-2b for High-Risk Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Melanoma
Interferon
Cognition
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in one of these categories:

1. Are to receive adjuvant treatment with interferon alpha-2b after complete surgical resection of high risk melanoma.
2. Have had a complete surgical resection of high risk melanoma, but have elected not to receive interferon alpha-2b and will be observed for disease progression only.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in cognitive function
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Daniel Combs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.