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Trial record 53 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00090870
Recruitment Status : Terminated (Pharmaceutical collaborator pulled funding.)
First Posted : September 8, 2004
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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
Biological: GM-CSF
Drug: thalidomide
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG-Intron, BM-CSF and Thalidomide
Hide Arm/Group Description

PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title PEG-Intron, BM-CSF and Thalidomide
Hide Arm/Group Description

PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  50.0%
>=65 years
5
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
1
  10.0%
Male
9
  90.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Response Rate
Hide Description To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Time Frame while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this endpoint was not collected
Arm/Group Title PEG-Intron, BM-CSF and Thalidomide
Hide Arm/Group Description:

PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this endpoint was not collected
Arm/Group Title PEG-Intron, BM-CSF and Thalidomide
Hide Arm/Group Description:

PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Frequency of Adverse Events Assessed by NCI CTC Version 2
Hide Description [Not Specified]
Time Frame From the first day of treatment until the end of treatment visit, an average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this endpoint was not collected
Arm/Group Title PEG-Intron, BM-CSF and Thalidomide
Hide Arm/Group Description:

PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame From registration until diease progression or death, whichever comes first.
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this endpoint was not collected
Arm/Group Title PEG-Intron, BM-CSF and Thalidomide
Hide Arm/Group Description:

PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From day 1 of study treatment until end of study, for an average of 6 months
Adverse Event Reporting Description Data for this endpoint was not collected
 
Arm/Group Title PEG-Intron, BM-CSF and Thalidomide
Hide Arm/Group Description

PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.

GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle

thalidomide: 200mg daily by mouth

All-Cause Mortality
PEG-Intron, BM-CSF and Thalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-Intron, BM-CSF and Thalidomide
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PEG-Intron, BM-CSF and Thalidomide
Affected / at Risk (%)
Total   0/0 
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: Kate Anderton
Organization: Medical University of South Carolina
Phone: 843-792-2708
EMail: anderton@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00090870     History of Changes
Other Study ID Numbers: CDR0000378049
MUSC-100614
CELGENE-MUSC-100614
MUSC-HR-10423
First Submitted: September 7, 2004
First Posted: September 8, 2004
Results First Submitted: May 4, 2018
Results First Posted: July 12, 2018
Last Update Posted: July 12, 2018