Recombinant Interferon Alfa-2b in Treating Patients With Melanoma
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ClinicalTrials.gov Identifier: NCT01460875 |
Recruitment Status :
Completed
First Posted : October 27, 2011
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | October 25, 2011 | |||
First Posted Date ICMJE | October 27, 2011 | |||
Results First Submitted Date ICMJE | May 4, 2018 | |||
Results First Posted Date ICMJE | November 2, 2018 | |||
Last Update Posted Date | November 2, 2018 | |||
Actual Study Start Date ICMJE | April 22, 2008 | |||
Actual Primary Completion Date | January 5, 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Level of Activated STAT1(Phospho-STAT1) [ Time Frame: up to 4 weeks ] Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.
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Original Primary Outcome Measures ICMJE |
Selection of the optimal recombinant interferon alfa-2b dose using signal transduction data [ Time Frame: Every 2 weeks for 4 weeks ] Accomplished through a one-sided confidence interval on the difference between observed response at a lower dose and the observed response at the standard dose. If we cannot declare non-inferiority for a dose, the patient will go back to the lowest dose at which non-inferiority can be claimed.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Recombinant Interferon Alfa-2b in Treating Patients With Melanoma | |||
Official Title ICMJE | Pilot Study of IFN-alpha-2b Dose Reduction With Dose Optimization | |||
Brief Summary | This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma | |||
Detailed Description | PRIMARY OBJECTIVES: I. To determine whether selection of the optimal IFN-alpha-2b (recombinant interferon alfa-2b) dose can be made using signal transduction data. SECONDARY OBJECTIVES: I. To determine the tolerability of adjuvant IFN-alpha-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy. II. The transcription of a panel of IFN-alpha-induced genes previously identified by microarray analysis will be determined by Real-Time reverse transcriptase-polymerase chain reaction (RT PCR) in order that the correlation between signal transducer and activator of transcription 1 (STAT1) phosphorylation and IFN-alpha gene regulation can be evaluated. III. Microarray analysis of patient peripheral blood mononuclear cells (PBMCs) will be used to evaluate the effect of dose-reduction on IFN-alpha gene expression. IV. In order to define the clinical role of tumor sensitivity to IFN-alpha, patient tumor biopsies taken prior to the administration of IFN-alpha will be systematically evaluated for cellular levels of janus kinase (Jak)-STAT signaling intermediates. OUTLINE: Patients receive recombinant interferon alfa-2b subcutaneously (SC) thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for 2 years. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment (interferon therapy)
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
34 | |||
Original Actual Enrollment ICMJE |
35 | |||
Actual Study Completion Date ICMJE | January 5, 2014 | |||
Actual Primary Completion Date | January 5, 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01460875 | |||
Other Study ID Numbers ICMJE | OSU-07033 NCI-2011-03121 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | William Carson, Ohio State University Comprehensive Cancer Center | |||
Study Sponsor ICMJE | William Carson | |||
Collaborators ICMJE | Schering-Plough | |||
Investigators ICMJE |
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PRS Account | Ohio State University Comprehensive Cancer Center | |||
Verification Date | October 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |