Trial Outcomes & Findings for Pilot Study of Interferon Alfa for Patients Who Have Received Cancer Vaccines (NCT NCT02159482)

Last Updated: 2014-07-25

Results Overview

Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Interferon-alfa-2a Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. Interferon Alfa-2a
Overall Study STARTED	11
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Interferon-alfa-2a Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. Interferon Alfa-2a
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	3

Baseline Characteristics

Pilot Study of Interferon Alfa for Patients Who Have Received Cancer Vaccines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interferon-alfa-2a n=11 Participants Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. Interferon Alfa-2a
Age, Customized 18 years and older	11 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	9 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	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Interferon-alfa-2a n=6 Participants Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. Interferon Alfa-2a
Proportion of Clinical Responders (Complete Response + Partial Response)	0 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Five subjects analysed due to one subject not completing blood draws.

The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis.

Outcome measures

Outcome measures
Measure	Interferon-alfa-2a n=5 Participants Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. Interferon Alfa-2a
Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response	60 percentage of participants

Adverse Events

Interferon-alfa-2a

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Interferon-alfa-2a n=6 participants at risk Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections. Interferon Alfa-2a
Investigations Platelet count decreased	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
General disorders Fever	33.3% 2/6 • Number of events 3 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
General disorders fatigue	66.7% 4/6 • Number of events 4 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
General disorders Chills	16.7% 1/6 • Number of events 2 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
General disorders Flu like symptoms	33.3% 2/6 • Number of events 2 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
General disorders Tongue swelling	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
General disorders Injection site reaction	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
Gastrointestinal disorders Dry Mouth	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
Psychiatric disorders Depression	33.3% 2/6 • Number of events 2 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
Metabolism and nutrition disorders anorexia	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.
Gastrointestinal disorders diarrhea	16.7% 1/6 • Number of events 1 • 2 months An adverse event is any adverse change from the study subject's baseline (pre-treatment) condition, including any clinical or laboratory test abnormality that occurs during the course of the proposed clinical study after treatment has started.

Additional Information

Dr. Michael Morse

Duke University

Phone: 919-681-3480

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place