Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer (NCT NCT00103116)

Results Overview

Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

six months post vaccine

Results posted on

2017-04-04

Participant Flow

Non-randomized open label; stage I-IIIB NSCLC. Closed to accrual in 2006 when defined phase I immunological endpoints were reached.

None excluded; all completed.

Participant milestones

Participant milestones
Measure	Vaccine therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine n=32 Participants therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Region of Enrollment Israel	1 participants n=5 Participants

PRIMARY outcome

Timeframe: six months post vaccine

Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.

Outcome measures

Outcome measures
Measure	Vaccine n=32 Participants therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization	22 participants with immunological response

SECONDARY outcome

Timeframe: five years post vaccine

Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine

Outcome measures

Outcome measures
Measure	Vaccine n=32 Participants therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
Number of Participants Alive Five Years Post Vaccine	20 participants

Adverse Events

Vaccine

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vaccine n=32 participants at risk therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
General disorders injection site reaction	50.0% 16/32 • Number of events 16 • five years

Additional Information

Edward Hirschowitz

UKentucky

Phone: 8596081981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place