MelanomaNCT02074605
Cognitive Effects of Interferon in Patients With Melanoma
An observational study of Melanoma, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Interferon alpha
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Melanoma
- Being tested
- Interferon alpha
- Keywords
- Melanoma, Interferon, Cognition
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon alphaBiological
Also called Intron-A
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Interferon alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
Cognitive function as assessed by a brief neurocognitive testing battery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Combs, University of Arizona
- Investigators
- Daniel Combs, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074605
- Sponsor's protocol ID
- 08-0389-02
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neurocognitive Function in Patients Treated With Adjuvant Interferon Alpha-2b for High-Risk Melanoma
- ClinicalTrials.gov ID
- NCT02074605
- Acronym / sponsor ID
- 08-0389-02
- Conditions
- Melanoma
- Keywords
- Melanoma, Interferon, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Patients with melanoma who qualify for interferon treatment, but choose not to receive it. |
| Interferon alpha | – | Biological: Interferon alphaPatients who receive high dose interferon alpha for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon alphaAlso: Intron-A | Biological | Interferon alpha |
Primary outcome
Change in cognitive function
Time frame: 1 month
Cognitive function as assessed by a brief neurocognitive testing battery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Results publicationCombs 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.
- Results publicationCombs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Combs, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.