Recombinant Interferon Alfa-2b in Treating Patients With Melanoma
|ClinicalTrials.gov Identifier: NCT01460875|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2011
Last Update Posted : May 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stage IA Skin Melanoma Stage IB Skin Melanoma Stage IIA Skin Melanoma Stage IIB Skin Melanoma Stage IIC Skin Melanoma Stage IIIA Skin Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma||Biological: recombinant interferon alfa-2b Other: laboratory biomarker analysis||Not Applicable|
I. To determine whether selection of the optimal IFN-alpha-2b (recombinant interferon alfa-2b) dose can be made using signal transduction data.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of IFN-alpha-2b Dose Reduction With Dose Optimization|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||January 2014|
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.
Biological: recombinant interferon alfa-2b
Other Names:Other: laboratory biomarker analysis
Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
Other Name: Correlative studies
- Selection of the optimal recombinant interferon alfa-2b dose using signal transduction data [ Time Frame: up to 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.
- Tolerability of adjuvant recombinant interferon alfa-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 [ Time Frame: up to 1 year ]
- Correlation between STAT1 phosphorylation and interferon alfa gene regulation [ Time Frame: Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months ]
- Effect of dose-reduction on interferon alfa gene expression [ Time Frame: Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months ]
- Clinical role of tumor sensitivity to recombinant interferon alfa-2b using cellular levels of Jak-STAT signaling intermediates [ Time Frame: Baseline and every other week prior to recombinant interferon alfa-2b administration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460875
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||William Carson, MD||Ohio State University|