Trial Outcomes & Findings for Dendritic Cell (DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With Prostate Cancer (NCT NCT00970203)
NCT ID: NCT00970203
Last Updated: 2020-11-03
Results Overview
The percentage of patients for which the alpha-DC1 vaccine was generated and for which 4 vaccine injections were administered (1 injection every 4 weeks).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-11-03
Participant Flow
Participant milestones
| Measure |
Cohort A
3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
Cohort B
3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dendritic Cell (DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Cohort A
n=7 Participants
3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
Cohort B
n=6 Participants
3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 6.9 • n=93 Participants
|
64 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
64 years
STANDARD_DEVIATION 6.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All treated and eligible patients
The percentage of patients for which the alpha-DC1 vaccine was generated and for which 4 vaccine injections were administered (1 injection every 4 weeks).
Outcome measures
| Measure |
Cohort A
n=7 Participants
3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
Cohort B
n=6 Participants
3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
|---|---|---|
|
Percentage of Patients to Successfully Generate and Administer the Alpha-DC1 Vaccine
|
100 percentage of participants
Interval 70.1 to 100.0
|
100 percentage of participants
Interval to 100.0
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All treated and eligible patients
The percentage of patients who experienced vaccine related toxicity.
Outcome measures
| Measure |
Cohort A
n=7 Participants
3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
Cohort B
n=6 Participants
3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
|---|---|---|
|
Tolerability and Toxicity of the Alpha-DC1 Vaccine
|
0 percentage of participants
Interval 0.0 to 29.2
|
0 percentage of participants
Interval 0.0 to 33.0
|
PRIMARY outcome
Timeframe: Approximately 18 monthsPopulation: Despite numerous attempts to obtain required data from the previous IND holder where the data is housed, including attempts to contact study PI and team, no responses were obtained and no data are available for this Outcome Measure.
The mean difference between time to relapse on androgen ablation plus alpha DC-1 vaccine vs androgen ablation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 18 monthsPopulation: The IND holder where the data is housed has stated that the data for this outcome was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 17 weeksPopulation: The IND holder where the data is housed has stated that the data for this outcome was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 18 to 24 monthsPopulation: The IND holder where the data is housed has stated that the data for this outcome was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 18 to 24 monthsPopulation: The IND holder where the data is housed has stated that the data for this outcome was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 18 to 24 monthsPopulation: The IND holder where the data is housed has stated that the data for this outcome was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A
n=7 participants at risk
3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
Cohort B
n=6 participants at risk
3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation
AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine: 3-5 x 10e6 cells total
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Eye disorders
Scleral disorder
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
28.6%
2/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
General disorders
Edema trunk
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
General disorders
Facial pain
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
General disorders
Fatigue
|
42.9%
3/7 • Between 6 and 18 months.
|
66.7%
4/6 • Between 6 and 18 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
General disorders
Infusion related reaction
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
General disorders
Injection site reaction
|
0.00%
0/7 • Between 6 and 18 months.
|
50.0%
3/6 • Between 6 and 18 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Investigations
Cholesterol high
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Investigations
White blood cell decreased
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
2/7 • Between 6 and 18 months.
|
50.0%
3/6 • Between 6 and 18 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • Between 6 and 18 months.
|
33.3%
2/6 • Between 6 and 18 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Between 6 and 18 months.
|
33.3%
2/6 • Between 6 and 18 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
28.6%
2/7 • Between 6 and 18 months.
|
50.0%
3/6 • Between 6 and 18 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Between 6 and 18 months.
|
33.3%
2/6 • Between 6 and 18 months.
|
|
Vascular disorders
Hot flashes
|
85.7%
6/7 • Between 6 and 18 months.
|
100.0%
6/6 • Between 6 and 18 months.
|
|
Vascular disorders
Hypertension
|
42.9%
3/7 • Between 6 and 18 months.
|
16.7%
1/6 • Between 6 and 18 months.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Between 6 and 18 months.
|
0.00%
0/6 • Between 6 and 18 months.
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 7168451300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place