Trial Outcomes & Findings for Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer (NCT NCT01446731)
NCT ID: NCT01446731
Last Updated: 2024-07-03
Results Overview
The induction of vaccine specific immune responses will be assessed using interferon-gamma ELISPOT assay
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
2 years
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Arm A
DC vaccine + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=21 Participants
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
n=19 Participants
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
n=5 Participants
|
70 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Biological material for testing was available for 18 patients
The induction of vaccine specific immune responses will be assessed using interferon-gamma ELISPOT assay
Outcome measures
| Measure |
Arm A
n=18 Participants
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
|---|---|---|
|
Number of Patients With Immunological Response
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPSA response will be evaluated by PSA measurements. A 50% decline in PSA is considered to be a response.
Outcome measures
| Measure |
Arm A
n=21 Participants
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
n=19 Participants
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
|---|---|---|
|
Number of Patients With PSA Response
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 yearsGraded according to common terminology criteria for adverse events (CTCAE) version 3.0.
Outcome measures
| Measure |
Arm A
n=21 Participants
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
|---|---|---|
|
Number of Patients With Adverse Event Considered Related to the Dendritic Cell Vaccine
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPFS was defined as the time from initiation of docetaxel to clinical, radiographic and/or PSA progression or death. PFS was described using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm A
n=21 Participants
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
n=19 Participants
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
|---|---|---|
|
Progression-free Survival
|
5.7 months
Interval 1.7 to 9.7
|
5.5 months
Interval 4.8 to 6.2
|
Adverse Events
Arm A
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm B
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=21 participants at risk
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
n=19 participants at risk
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Aortic injury
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
Other adverse events
| Measure |
Arm A
n=21 participants at risk
DC vaccine (mRNA transfected dendritic cell) + Docetaxel
mRNA transfected dendritic cell: Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
Arm B
n=19 participants at risk
Docetaxel alone
Docetaxel: Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
alopecia
|
81.0%
17/21 • Number of events 17
|
94.7%
18/19 • Number of events 18
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/21
|
5.3%
1/19 • Number of events 1
|
|
Eye disorders
Vision impairment
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Weigt loss
|
28.6%
6/21 • Number of events 6
|
15.8%
3/19 • Number of events 3
|
|
Immune system disorders
Allergic reaction
|
28.6%
6/21 • Number of events 6
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Fatigue
|
85.7%
18/21 • Number of events 18
|
84.2%
16/19 • Number of events 16
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/21
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
7/21 • Number of events 7
|
42.1%
8/19 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
61.9%
13/21 • Number of events 13
|
73.7%
14/19 • Number of events 14
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Diarrhea
|
23.8%
5/21 • Number of events 5
|
36.8%
7/19 • Number of events 7
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
9.5%
2/21 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/21
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Peripheral neuropathy
|
52.4%
11/21 • Number of events 11
|
73.7%
14/19 • Number of events 14
|
|
General disorders
Edema limbs
|
9.5%
2/21 • Number of events 2
|
21.1%
4/19 • Number of events 4
|
|
General disorders
Injection site reaction
|
9.5%
2/21 • Number of events 2
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
28.6%
6/21 • Number of events 6
|
26.3%
5/19 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.5%
2/21 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
1/21 • Number of events 1
|
21.1%
4/19 • Number of events 4
|
|
Blood and lymphatic system disorders
Anemia
|
19.0%
4/21 • Number of events 4
|
21.1%
4/19 • Number of events 4
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
28.6%
6/21 • Number of events 6
|
15.8%
3/19 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
28.6%
6/21 • Number of events 6
|
26.3%
5/19 • Number of events 5
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
9.5%
2/21 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Infection
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place