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NCT Number: NCT02074605

Cognitive Effects of Interferon in Patients With Melanoma

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon alpha

Biological

Other names: Intron-A

Primary outcomes

  1. Change in cognitive function

    Time frame: 1 month

    Cognitive function as assessed by a brief neurocognitive testing battery

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 28, 2014
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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