Trial Outcomes & Findings for Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12 (NCT NCT00622401)

Results Overview

Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

3 years

Results posted on

2017-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Dendritic Cell/Tumor Fusion Vaccine Only Dendritic Cell/Tumor Fusion Vaccine Only Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells	Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 Dendritic Cell/tumor fusion vaccine and low dose IL-12 Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells Interleukin-12: Given subcutaneously at dose of 30ng/kg
Overall Study STARTED	6	2
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Dendritic Cell/Tumor Fusion Vaccine Only Dendritic Cell/Tumor Fusion Vaccine Only Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells	Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 Dendritic Cell/tumor fusion vaccine and low dose IL-12 Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells Interleukin-12: Given subcutaneously at dose of 30ng/kg	Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I Dendritic Cell/tumor fusion vaccine and higher dose IL-12 Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells Interleukin-12: Given subcutaneously at dose of 100ng/kg
Overall Study Disease progression prior to treatment	3	2	0

Baseline Characteristics

Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Dendritic Cell/Tumor Fusion Vaccine Only n=6 Participants Dendritic Cell/Tumor Fusion Vaccine Only Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells	Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 n=2 Participants Dendritic Cell/tumor fusion vaccine and low dose IL-12 Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells Interleukin-12: Given subcutaneously at dose of 30ng/kg	Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I Dendritic Cell/tumor fusion vaccine and higher dose IL-12 Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells Interleukin-12: Given subcutaneously at dose of 100ng/kg	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	—	6 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	—	2 Participants n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	—	8 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	2 participants n=7 Participants	—	8 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 years

Population: All three patients experienced adverse events that were determined to be at least possibly related to the vaccine. The number of times each toxicity was observed is captured in the adverse events section.

Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.

Outcome measures

Outcome measures
Measure	Group 1 n=3 Participants Dendritic Cell/Tumor Fusion Vaccine Only Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells	Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 Dendritic Cell/tumor fusion vaccine and low dose IL-12 Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells Interleukin-12: Given subcutaneously at dose of 30ng/kg	Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I Dendritic Cell/tumor fusion vaccine and higher dose IL-12 Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells Interleukin-12: Given subcutaneously at dose of 100ng/kg
Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine	3 participants	—	—

SECONDARY outcome

Timeframe: 3 years

Population: This outcome was not measured because no patients were treated with rhIL-12.

This outcome was not measured because no patients were treated with rhIL-12.

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 n=3 participants at risk Dendritic Cell/Tumor Fusion Vaccine Only Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells
Investigations Vaccine Site Reaction	66.7% 2/3 • Number of events 3
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 2
General disorders Myalgias	33.3% 1/3 • Number of events 1
General disorders Rash	33.3% 1/3 • Number of events 1
Nervous system disorders Pain	33.3% 1/3 • Number of events 1

Additional Information

David Avigan, MD

Beth Israel Deaconess Medical Center

Phone: 617-667-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place