Trial Outcomes & Findings for PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer (NCT NCT00090870)
NCT ID: NCT00090870
Last Updated: 2018-07-12
Results Overview
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
TERMINATED
PHASE2
10 participants
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
2018-07-12
Participant Flow
Participant milestones
| Measure |
PEG-Intron, BM-CSF and Thalidomide
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 Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
PEG-Intron, BM-CSF and Thalidomide
n=10 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every yearPopulation: Data for this endpoint was not collected
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.Population: Data for this endpoint was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first day of treatment until the end of treatment visit, an average of 6 monthsPopulation: Data for this endpoint was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From registration until diease progression or death, whichever comes first.Population: Data for this endpoint was not collected
Outcome measures
Outcome data not reported
Adverse Events
PEG-Intron, BM-CSF and Thalidomide
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place