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Trial record 7 of 10 for:    "Clear Cell Renal Cell Carcinoma" | "Interferon alpha-2"

PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00589550
Recruitment Status : Terminated (low accrual)
First Posted : January 9, 2008
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Thomas Olencki, Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Cancer
Interventions Biological: PEG-interferon alfa-2b
Drug: Sorafenib
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: reverse transcriptase-polymerase chain reaction
Other: flow cytometry
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Period Title: Overall Study
Started 1
Withdrew From Study 1
Completed 0
Not Completed 1
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Patient
Age18-60 Number Analyzed 1 participants
1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Patients
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate
Hide Description [Not Specified]
Time Frame up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description:

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.
Hide Description [Not Specified]
Time Frame up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description:

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.
Hide Description [Not Specified]
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description:

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.
Hide Description [Not Specified]
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description:

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description:

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome
Hide Description [Not Specified]
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description:

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood
Hide Description [Not Specified]
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description:

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline until study discontinuation
Adverse Event Reporting Description The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used to grade and quantify toxic events associated with therapy.
 
Arm/Group Title Peginterferon Alfa-2b
Hide Arm/Group Description

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Sorafenib

gene expression analysis

polymerase chain reaction

reverse transcriptase-polymerase chain reaction

flow cytometry

immunoenzyme technique

laboratory biomarker analysis

All-Cause Mortality
Peginterferon Alfa-2b
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Peginterferon Alfa-2b
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Peginterferon Alfa-2b
Affected / at Risk (%)
Total   0/1 (0.00%) 
Trial was terminated due to low patient accrual
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Olencki, DO
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-2886
EMail: Thomas.Olencki@osumc.edu
Layout table for additonal information
Responsible Party: Thomas Olencki, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00589550     History of Changes
Other Study ID Numbers: OSU-06113
First Submitted: January 5, 2008
First Posted: January 9, 2008
Results First Submitted: May 6, 2015
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015