Trial Outcomes & Findings for Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer (NCT NCT00345293)
NCT ID: NCT00345293
Last Updated: 2016-04-18
Results Overview
adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
through week 29
Results posted on
2016-04-18
Participant Flow
Participant milestones
| Measure |
DC/PC3 Vaccine-selected
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10\^6 DCs. DCs were made from precursors isolated using antibodies.
|
DC/PC3- Adherent
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10\^6 DCs. DCs were made from precursors isolated using the adherence method.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
3
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
DC/PC3 Vaccine-selected
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10\^6 DCs. DCs were made from precursors isolated using antibodies.
|
DC/PC3- Adherent
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10\^6 DCs. DCs were made from precursors isolated using the adherence method.
|
|---|---|---|
|
Overall Study
Unable to access line for sample
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
Baseline characteristics by cohort
| Measure |
DC/PC3 Vaccine
n=13 Participants
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
|
|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: through week 29adverse events
Outcome measures
| Measure |
DC/PC3 Vaccine
n=13 Participants
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
|
DC/PC3- Adherent
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).
Dendritic cells were made from the adherent subset of peripheral blood mononuclear cells.
|
|---|---|---|
|
Toxicity
Serious Adverse Events
|
2 events
|
—
|
|
Toxicity
Other Adverse Events
|
204 events
|
—
|
SECONDARY outcome
Timeframe: pre and post treatmentPopulation: One other participant in DC/PC3 vaccine-Selected group not analyzed due to failed controls in assay.
The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).
Outcome measures
| Measure |
DC/PC3 Vaccine
n=7 Participants
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
|
DC/PC3- Adherent
n=3 Participants
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).
Dendritic cells were made from the adherent subset of peripheral blood mononuclear cells.
|
|---|---|---|
|
Immunogenicity
|
62 counts per minute
Interval -112.0 to 4493.0
|
9461 counts per minute
Interval 985.0 to 9985.0
|
SECONDARY outcome
Timeframe: Post treatmentPopulation: This data was not collected due to differences in immunogenicity based on different dendritic cell preparations. This data was no longer relevant.
Outcome measures
Outcome data not reported
Adverse Events
DC/PC3 Vaccine
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DC/PC3 Vaccine
n=13 participants at risk
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
|
|---|---|
|
Cardiac disorders
chest pain
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Cardiac disorders
arrhythmia
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
Other adverse events
| Measure |
DC/PC3 Vaccine
n=13 participants at risk
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
|
|---|---|
|
Blood and lymphatic system disorders
absolute lymphocyte, low
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
acid phosphatase, high
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
albumin, low
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
albumin, trace, urine
|
15.4%
2/13 • Number of events 3
Common toxicity criteria v4
|
|
General disorders
alkaline phosphatase, high
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Gastrointestinal disorders
ALT, high
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
ANA, high
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
ANC, low
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Hepatobiliary disorders
AST, high
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
General disorders
bacteria, urine, few
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
basophil, high
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
bilirubin, urine, small
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Renal and urinary disorders
blood, urine, trace
|
15.4%
2/13 • Number of events 3
Common toxicity criteria v4
|
|
General disorders
BUN, high
|
7.7%
1/13 • Number of events 3
Common toxicity criteria v4
|
|
General disorders
calcium, ionized, low
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
chloride, high
|
30.8%
4/13 • Number of events 6
Common toxicity criteria v4
|
|
General disorders
CO2, high
|
53.8%
7/13 • Number of events 12
Common toxicity criteria v4
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
creatinine, high
|
23.1%
3/13 • Number of events 4
Common toxicity criteria v4
|
|
Renal and urinary disorders
crystals, urine
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
Gastrointestinal disorders
diarrhea
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
fatigue
|
15.4%
2/13 • Number of events 5
Common toxicity criteria v4
|
|
General disorders
glucose, high
|
23.1%
3/13 • Number of events 4
Common toxicity criteria v4
|
|
General disorders
glucose, low
|
15.4%
2/13 • Number of events 3
Common toxicity criteria v4
|
|
General disorders
headache
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Gastrointestinal disorders
heartburn
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
hematocrit, low
|
23.1%
3/13 • Number of events 5
Common toxicity criteria v4
|
|
General disorders
hematoma
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
hemoglobin, low
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
Renal and urinary disorders
hemorrhage, GU, bladder
|
7.7%
1/13 • Number of events 2
Common toxicity criteria v4
|
|
General disorders
epistaxis
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
injection site reaction
|
84.6%
11/13 • Number of events 28
Common toxicity criteria v4
|
|
General disorders
INR, low
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
ketones, urine, high
|
15.4%
2/13 • Number of events 3
Common toxicity criteria v4
|
|
General disorders
leuko est, urine, high
|
15.4%
2/13 • Number of events 3
Common toxicity criteria v4
|
|
General disorders
lightheadedness
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
low back pain
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
General disorders
LUC, high
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
lymphocytes, %, low
|
23.1%
3/13 • Number of events 3
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
MCHC, high
|
46.2%
6/13 • Number of events 9
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
monocytes, %, high
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
neutrophils, %, high
|
23.1%
3/13 • Number of events 3
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
neutrophils, %, low
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
numbness/tingling
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
Cardiac disorders
chest pain
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
pain
|
46.2%
6/13 • Number of events 6
Common toxicity criteria v4
|
|
General disorders
pH, urine, high
|
23.1%
3/13 • Number of events 5
Common toxicity criteria v4
|
|
General disorders
platelet, high
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
platelets, low
|
7.7%
1/13 • Number of events 3
Common toxicity criteria v4
|
|
General disorders
potassium, high
|
15.4%
2/13 • Number of events 5
Common toxicity criteria v4
|
|
General disorders
presyncope
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Cardiac disorders
Prolonged QTc interval
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
pulmonary nodules
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
rash
|
15.4%
2/13 • Number of events 3
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
RBC, low
|
23.1%
3/13 • Number of events 5
Common toxicity criteria v4
|
|
Renal and urinary disorders
RBC, urine, high
|
46.2%
6/13 • Number of events 10
Common toxicity criteria v4
|
|
General disorders
RDW, high
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
rheumatoid factor, positive
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Skin and subcutaneous tissue disorders
rosecea
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Immune system disorders
seasonal allergies
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Renal and urinary disorders
specific gravity, urine, high
|
38.5%
5/13 • Number of events 6
Common toxicity criteria v4
|
|
Renal and urinary disorders
specific gravity, urine, low
|
30.8%
4/13 • Number of events 5
Common toxicity criteria v4
|
|
General disorders
swollen glands
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
thyroid nodules
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
total bilirubin, high
|
15.4%
2/13 • Number of events 2
Common toxicity criteria v4
|
|
General disorders
total protein, low
|
7.7%
1/13 • Number of events 2
Common toxicity criteria v4
|
|
General disorders
URI
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
General disorders
vasovagal episode
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Gastrointestinal disorders
vomiting
|
7.7%
1/13 • Number of events 1
Common toxicity criteria v4
|
|
Blood and lymphatic system disorders
WBC, low
|
23.1%
3/13 • Number of events 4
Common toxicity criteria v4
|
Additional Information
Mayu Frank, MS, ANP, Clinical Research Nurse Practitioner
Rockefeller University
Phone: 212-327-7443
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place