Cognitive Effects of Interferon in Patients With Melanoma

NCT02074605 | Completed

• 1 other identifier: 08-0389-02
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Melanoma; Interferon; Cognition

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function

  Cognitive function as assessed by a brief neurocognitive testing battery

  1 month

Study Arms (2)

Observation

Patients with melanoma who qualify for interferon treatment, but choose not to receive it.

Interferon alpha

Patients who receive high dose interferon alpha for 4 weeks

Biological: Interferon alpha

Interventions

Interferon alpha BIOLOGICAL

Also known as: Intron-A

Interferon alpha

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Interferon-alpha; Introns

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Daniel Combs, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 28, 2014
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

US (1)