Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer (NCT NCT00103142)
NCT ID: NCT00103142
Last Updated: 2015-10-14
Results Overview
Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
2 years
Results posted on
2015-10-14
Participant Flow
This was a 7 site study where patients were recruited from medical clinics and the patient's primary oncologist and study team approached the patient about the study. Patients were recruited for this study from January 2005 and September 2009.
The study was designed to treat 72 subjects. Total number of enrollment is 74 because enrollment reflects the number of subjects that signed consent and were randomized to the study but did not necessarily receive study drug or complete study drug.
Participant milestones
| Measure |
PANVAC-V + PANVAC-F + DC
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
|
PANVAC-V + PANVAC-F + GM-CSF
Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
|
Overall Study
COMPLETED
|
33
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
PANVAC-V + PANVAC-F + DC
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
|
PANVAC-V + PANVAC-F + GM-CSF
Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Progression of disease
|
2
|
1
|
Baseline Characteristics
Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Experimental PANVAC-V + PANVAC-F + DC
n=37 Participants
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-Carcinoembryonic antigen (CEA)-Mucin 1 (MUC-1)-TRIad of COstimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneous (SC) and intradermally (ID) on days 28, 56, and 84.
|
Experimental PANVAC-V + PANVAC-F + GM-CSF
n=37 Participants
Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (Granulocyte-macrophage colony-stimulating factor or GM-CSF) subcutaneous (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
n=5 Participants
|
52.0 years
n=7 Participants
|
53.5 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
37 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Sites of metastasis
Liver
|
26 participants
n=5 Participants
|
31 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Sites of metastasis
Lung
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Number of nodules
1 nodules
|
11 participants
n=5 Participants
|
17 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Number of nodules
2-4 nodules
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Number of nodules
>4 nodules
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Number of nodules
unknown
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Carcinoembryonic antigen (CEA)
|
2.0 mcg/L
n=5 Participants
|
1.8 mcg/L
n=7 Participants
|
1.9 mcg/L
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsRecurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.
Outcome measures
| Measure |
PANVAC-V + PANVAC-F + DC
n=16 Participants
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-carcinoembryonic antigen (CEA)- mucin 1 (MUC-1)-TRiad of Costimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
|
PANVAC-V + PANVAC-F + GM-CSF
n=20 Participants
Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
|
|---|---|---|
|
Recurrence-free Survival at 2 Years
|
13 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 13 weeksCEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.
Outcome measures
| Measure |
PANVAC-V + PANVAC-F + DC
n=35 Participants
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-carcinoembryonic antigen (CEA)- mucin 1 (MUC-1)-TRiad of Costimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
|
PANVAC-V + PANVAC-F + GM-CSF
n=32 Participants
Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
|
|---|---|---|
|
Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay
|
9 participants
|
4 participants
|
Adverse Events
Arm I
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Arm II
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I
n=35 participants at risk
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
|
Arm II
n=36 participants at risk
Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hematologic Adverse Events
|
22.9%
8/35 • Number of events 8
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
22.2%
8/36 • Number of events 9
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Cardiac disorders
Cardiac
|
2.9%
1/35 • Number of events 1
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
13.9%
5/36 • Number of events 5
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
General disorders
CONSTITUTIONAL SYMPTOMS
|
51.4%
18/35 • Number of events 18
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
36.1%
13/36 • Number of events 13
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Skin and subcutaneous tissue disorders
Skin
|
85.7%
30/35 • Number of events 30
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
63.9%
23/36 • Number of events 23
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Endocrine disorders
Endocrine
|
2.9%
1/35 • Number of events 1
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
0.00%
0/36
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Gastrointestinal disorders
GI
|
14.3%
5/35 • Number of events 5
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
22.2%
8/36 • Number of events 8
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Infections and infestations
Infection
|
0.00%
0/35
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
2.8%
1/36 • Number of events 1
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Metabolism and nutrition disorders
Metabolic
|
40.0%
14/35 • Number of events 14
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
25.0%
9/36 • Number of events 9
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE
|
5.7%
2/35 • Number of events 2
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
2.8%
1/36 • Number of events 1
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
|
Nervous system disorders
NEUROLOGY
|
20.0%
7/35 • Number of events 7
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
27.8%
10/36 • Number of events 10
Adverse Events were only collected/assessed for participants who received at least one dose of intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place