Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer (NCT NCT00814892)
NCT ID: NCT00814892
Last Updated: 2013-11-05
Results Overview
Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level \<200.0 ng/mL.
TERMINATED
PHASE2
2 participants
One year
2013-11-05
Participant Flow
Two (2) participants were recruited between Jan 2009 and March 2010 at Mayo Clinic. This trial was permanently closed in March 2010 due to funding issues. Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
Participant milestones
| Measure |
DC-APCC
Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
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2
|
|
Overall Study
COMPLETED
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0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
DC-APCC
Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Disease Progression
|
1
|
|
Overall Study
Study Termination
|
1
|
Baseline Characteristics
Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: One yearPopulation: Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level \<200.0 ng/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every cycle during treatment (up to 14 cycles)Population: Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Registration to Prostate-cancer specific mortality (Up to 3 years)Population: Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Registration to PSA progression (Up to 3 years)Population: Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value. In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed. The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response). For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved (see above). All end dates require a confirmatory PSA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
PSA-based response was defined as a PSA decline of at least 50%, which must be confirmed by a second PSA value in 4 or more weeks later. The duration of PSA-based response are measured from the first time point at which the PSA has declined by at least 50% (which must eventually be confirmed by a second value) until PSA has increased back to 50% of the original on-study value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and cycle 1Population: Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
European Orgnisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 for cancer patients composed of 5 functional scales, 3 symptom scales, a global health status QOL scale, and six single items. Scores for each scale/item were calculated according to the questionnaire's scoring algorithm and range in 0 to 100, with high score represents high healthy level of functioning, high QOL or high level of symptomatology/problems. Change: Scores at cycle 1 minus scores at baseline. Change from baseline in QOL will also be evaluated at cycle 6, 10, 15 and every 6 months during observation phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.
PFS based on radiographic criteria was defined as the time from registration to the time of radiographic progression. A confirmed progression was defined as one for which radiological evidence of a new lesion is found following CT and/or bone scans.
Outcome measures
Outcome data not reported
Adverse Events
DC-APCC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place