Trial Outcomes & Findings for Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer (NCT NCT00776295)

Results Overview

Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

up to one year

Results posted on

2013-01-24

Participant milestones
Measure	p53 Vaccination Dendritic cell p53 vaccination
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer

Baseline characteristics by cohort
Measure	p53 Vaccination n=2 Participants Dendritic cell p53 vaccination
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

Timeframe: up to one year

Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death

Outcome measures
Measure	p53 Vaccination n=2 Participants Dendritic cell p53 vaccination
Number of Subjects Meeting 1-year Overall Survival	2 participants

Timeframe: up to 3 years

3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC

Outcome measures
Measure	p53 Vaccination n=2 Participants Dendritic cell p53 vaccination
3 Year Progression-free Survival	0 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

H. Lee Moffitt Cancer Center

Phone: 961-1350000