Ignite Creation Date:
2024-05-06 @ 12:00 AM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01460875
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2011-10-25
Brief Title:
Recombinant Interferon Alfa-2b in Treating Patients With Melanoma
Sponsor:
William Carson
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Pilot Study of IFN-alpha-2b Dose Reduction With Dose Optimization
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-03121 | REGISTRY | CTRP Clinical Trial Reporting Program | None |