- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074605
Cognitive Effects of Interferon in Patients With Melanoma
A Pilot Study of Neurocognitive Function in Patients Treated With Adjuvant Interferon Alpha-2b for High-Risk 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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients in one of these categories:
- Are to receive adjuvant treatment with interferon alpha-2b after complete surgical resection of high risk melanoma.
- 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.
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Observation
Patients with melanoma who qualify for interferon treatment, but choose not to receive it.
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Interferon alpha
Patients who receive high dose interferon alpha for 4 weeks
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive function
Time Frame: 1 month
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Cognitive function as assessed by a brief neurocognitive testing battery
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1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
Other Study ID Numbers
- 08-0389-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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