Trial Outcomes & Findings for Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients (NCT NCT00913913)

Results Overview

median progression free survival

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

5 years

Results posted on

2015-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab,IL-2, IFN, DC Vaccine Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day) DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks IL-2: IL-2 18 MiU/m2 CI 5 days IFN: IFN 6 MiU subc TIW
Overall Study STARTED	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab,IL-2, IFN, DC Vaccine n=8 Participants Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day) DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks IL-2: IL-2 18 MiU/m2 CI 5 days IFN: IFN 6 MiU subc TIW
Age, Continuous	55 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

median progression free survival

Outcome measures

Outcome measures
Measure	Bevacizumab,IL-2, IFN, DC Vaccine n=8 Participants Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day) DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks IL-2: IL-2 18 MiU/m2 CI 5 days IFN: IFN 6 MiU subc TIW
Progression Free Survival	340 DAYS Interval 73.0 to 1582.0

SECONDARY outcome

Timeframe: 5 years

To characterize the clinical and autoimmune related toxicity profile of the combined treatment regimen using CTCAE 3. Toxicity reported are those expected from high dose IL-2 and were not considered adverse events.

Outcome measures

Outcome measures
Measure	Bevacizumab,IL-2, IFN, DC Vaccine n=8 Participants Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day) DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks IL-2: IL-2 18 MiU/m2 CI 5 days IFN: IFN 6 MiU subc TIW
To Characterize the Number of Participants With Clinical and Autoimune Related Toxicity of Treatment	8 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, day 28, day 70

Population: Peripheral blood lymphocyte subsets: 5 subjects at baseline and same 5 at day 70. 6 subjects analyzed at day 28

percent of CD4 and CD8 positive lymphocyte subsets

Outcome measures

Outcome measures
Measure	Bevacizumab,IL-2, IFN, DC Vaccine n=6 Participants Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day) DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks IL-2: IL-2 18 MiU/m2 CI 5 days IFN: IFN 6 MiU subc TIW
Measure of Percent of CD4 and CD8 Lymphocyte Subsets CD4 Central memory: baseline	0.50 percentage of total lymphocytes Interval 0.21 to 1.42
Measure of Percent of CD4 and CD8 Lymphocyte Subsets CD4 Central memory: Day 28	1.71 percentage of total lymphocytes Interval 0.8 to 2.6
Measure of Percent of CD4 and CD8 Lymphocyte Subsets CD4 Central memory: Day 70	0.69 percentage of total lymphocytes Interval 0.14 to 1.93
Measure of Percent of CD4 and CD8 Lymphocyte Subsets CD8 Central memory: baseline	1.61 percentage of total lymphocytes Interval 0.32 to 5.36
Measure of Percent of CD4 and CD8 Lymphocyte Subsets CD8 Central memory: day 28	4.74 percentage of total lymphocytes Interval 2.49 to 7.79
Measure of Percent of CD4 and CD8 Lymphocyte Subsets CD8 Central memory: day 70	2.76 percentage of total lymphocytes Interval 0.18 to 9.84

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 70

clinical response by RECIST 1.1

Outcome measures

Outcome measures
Measure	Bevacizumab,IL-2, IFN, DC Vaccine n=8 Participants Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day) DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks IL-2: IL-2 18 MiU/m2 CI 5 days IFN: IFN 6 MiU subc TIW
Clinical Response	4 participants

Adverse Events

Bevacizumab,IL-2, IFN, DC Vaccine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab,IL-2, IFN, DC Vaccine n=8 participants at risk Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day) DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks IL-2: IL-2 18 MiU/m2 CI 5 days IFN: IFN 6 MiU subc TIW
Hepatobiliary disorders hyperbilirubinemia	12.5% 1/8 • Number of events 1 • From time patient first dosed with any study specific medications to end of study. Subjects were evaluated until progression. The median time of follow up was 340 days with a range from 73 to 1582 days.
Hepatobiliary disorders Liver dysfunction/Failure	12.5% 1/8 • Number of events 1 • From time patient first dosed with any study specific medications to end of study. Subjects were evaluated until progression. The median time of follow up was 340 days with a range from 73 to 1582 days.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marc Ernstoff

Dartmouth-Hitchcock Medical Center

Phone: 603-650-5534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place