Trial Outcomes & Findings for Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas (NCT NCT00084383)

Last Updated: 2013-07-22

Results Overview

Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Participants were followed for the duration of the study, an average of 2 years

Results posted on

2013-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	GVAX Pancreatic Cancer Vaccine
Overall Study STARTED	60
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GVAX Pancreatic Cancer Vaccine n=60 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=99 Participants
Age, Categorical >=65 years	27 Participants n=99 Participants
Age Continuous	62 years STANDARD_DEVIATION 9.375 • n=99 Participants
Sex: Female, Male Female	23 Participants n=99 Participants
Sex: Female, Male Male	37 Participants n=99 Participants
Region of Enrollment United States	60 participants n=99 Participants

PRIMARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 2 years

Outcome measures

Outcome measures
Measure	GVAX Pancreatic Cancer Vaccine n=60 Participants
Overall Survival	24.8 Months Interval 21.2 to 31.6

PRIMARY outcome

Timeframe: Participants were followed for the duration of the study, an average of 2 years

Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.

Outcome measures

Outcome measures
Measure	GVAX Pancreatic Cancer Vaccine n=60 Participants
Disease-free Survival	17.3 Months Interval 14.6 to 22.8

SECONDARY outcome

Timeframe: 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Continuous

The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.

Outcome measures

Outcome data not reported

Adverse Events

GVAX Pancreatic Cancer Vaccine

Serious events: 2 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GVAX Pancreatic Cancer Vaccine n=60 participants at risk
Hepatobiliary disorders Pain, Cancer related	100.0% 1/1 • Number of events 1
Hepatobiliary disorders Biliary Obstruction, secondary to progessive disease	100.0% 1/1 • Number of events 1

Other adverse events

Other adverse events
Measure	GVAX Pancreatic Cancer Vaccine n=60 participants at risk
Blood and lymphatic system disorders Eosinophils, elevated	28.3% 17/60 • Number of events 30
General disorders Chills	18.3% 11/60 • Number of events 12
General disorders Fatigue	15.0% 9/60 • Number of events 11
General disorders Fever	18.3% 11/60 • Number of events 19
General disorders Flu like symptoms	11.7% 7/60 • Number of events 13
Skin and subcutaneous tissue disorders Blister	6.7% 4/60 • Number of events 4
Skin and subcutaneous tissue disorders Erythema	100.0% 60/60 • Number of events 172
Skin and subcutaneous tissue disorders Induration	100.0% 60/60 • Number of events 171
Skin and subcutaneous tissue disorders Pruritis	85.0% 51/60 • Number of events 152
Skin and subcutaneous tissue disorders Tenderness	91.7% 55/60 • Number of events 142
Skin and subcutaneous tissue disorders Vaccine site flare	11.7% 7/60 • Number of events 12
Skin and subcutaneous tissue disorders Rash	11.7% 7/60 • Number of events 13
Gastrointestinal disorders Nausea	11.7% 7/60 • Number of events 8
Musculoskeletal and connective tissue disorders Myalgia	16.7% 10/60 • Number of events 12
Nervous system disorders Dizziness	5.0% 3/60 • Number of events 4
Nervous system disorders Headache	8.3% 5/60 • Number of events 7
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 5/60 • Number of events 5

Additional Information

Dr. Daniel Laheru

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 410-955-8974

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place