Prostatic NeoplasmsPhase 2NCT01446731
Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer
A Phase 2 study testing mRNA transfected dendritic cell and Docetaxel in people with Prostatic Neoplasms, run by Inge Marie Svane at 2 sites in Denmark.
Trial summary
This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC). Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- mRNA transfected dendritic cell and Docetaxel
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2011to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological verified CRMPC in progression, defined by
- RECIST-criteria and/or
- PSA increase to more than baseline in two consecutive measurements
- Treatment with Docetaxel is indicated
- Age > 18 years old
- ECOG performance status ≤2
- Life expectancy > 3 months
- Normal organ function
Who cannot join
- Other malignant tumors
- Severe heard or lung disorders
- Infection with HIV, hepatitis, tuberculosis.
- Severe allergy or previous anaphylactic reactions
- Active autoimmune disease
- Treatment with immunosuppressive drugs (including prednisolon, methotrexate)7. Co-treatment with other experimental treatments, other antineoplastic treatment.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Center for Cancer Immune Therapy, Dept. of Haematology/Oncology
Copenhagen, Herlev, 2730
Department of Oncology, Herlev Hospital
Herlev, 2730
About this study
Official title: Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC).
Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone.
The primary objective is to evaluate the vaccine specific immune response and patients will be evaluated with blood tests and DTH reactions during the treatment course.
Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.
Read the detailed description
Treatment in details:
Dendritic cell (DC) vaccination The DC vaccine consists of adherent monocytes collected by leukapheresis. Monocytes are stimulated with GM-CSF and IL-4, and IL-1β, TNFα, IL-6 and PGE2 are used for further maturation.
DCs are transfected with PSA, PAP, survivin and hTERT mRNA. DC vaccines will only be given to patients in ARM A
Docetaxel:
Docetaxel will be given as an i.v. infusion every third week, 75 mg/m2 according to standard treatment. Patients will be pretreated with prednisolon before infusion with Docetaxel. Continuous treatment with prednisolon will not be administered.
Treatment schedule:
The DC vaccination will be administered once a week in two out of three weeks for the first 12 weeks. After 12 weeks the DC vaccination will be given once every three weeks as long as Docetaxel is given. If the disease does not progress but the patient stop treatment with Docetaxel (because of side effects) the vaccine treatment can continue until disease progression.
Evaluation in details:
Immunological evaluation:
Blood tests:
100 ml blood will be drawn from the patient together with the first (baseline), the third and the fourth infusion of Docetaxel, and every third month thereafter.
DTH:
DTH with 3 i.d. injections consisting of media (neg. test), naked DCs and mRNA transfected DCs will be performed at baseline (together with 1st vaccine), together with the 5th vaccine and after three months of treatment (8th vaccine). 48 hours after the DTH at 5th vaccine a biopsy will be taken from the DTH area.
Clinical evaluation:
PSA:
Patients will be evaluated with PSA measurements during the treatment. All patients will receive at least 4 treatments with Docetaxel even if PSA is rising.
18F-NaF ("bone") PET/CT scan: All patients will have a bone-PET/CT scan at baseline. For patients with measurable lesions a PET/CT scan will be performed every three months.
- Conditions
- Prostatic Neoplasms
- Being tested
- mRNA transfected dendritic cell, Docetaxel
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA transfected dendritic cellBiological
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).
DocetaxelDrug
Also called taxotere
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | DC vaccine (mRNA transfected dendritic cell) + Docetaxel Receives: Biological: mRNA transfected dendritic cell; Drug: Docetaxel |
| Arm B | Active comparator | Docetaxel alone Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Immunological Response
The induction of vaccine specific immune responses will be assessed using interferon-gamma ELISPOT assay
Measured: 2 years
Secondary outcomes (3)
Number of Patients With PSA Response
PSA response will be evaluated by PSA measurements. A 50% decline in PSA is considered to be a response.
Measured: 2 years
Number of Patients With Adverse Event Considered Related to the Dendritic Cell Vaccine
Graded according to common terminology criteria for adverse events (CTCAE) version 3.0.
Measured: 2 years
Progression-free Survival
PFS 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
- Investigators
- Per Kongsted, MD, Principal investigator, CCIT / Department of Oncology, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446731
- Sponsor's protocol ID
- UR1121
- Status last verified
- Jan 2024
- First submitted
- 2 Oct 2011
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT01446731
- Acronym / sponsor ID
- UR1121
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC).
Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone.
The primary objective is to evaluate the vaccine specific immune response and patients will be evaluated with blood tests and DTH reactions during the treatment course.
Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.
Detailed description
Treatment in details:
Dendritic cell (DC) vaccination The DC vaccine consists of adherent monocytes collected by leukapheresis. Monocytes are stimulated with GM-CSF and IL-4, and IL-1β, TNFα, IL-6 and PGE2 are used for further maturation.
DCs are transfected with PSA, PAP, survivin and hTERT mRNA. DC vaccines will only be given to patients in ARM A
Docetaxel:
Docetaxel will be given as an i.v. infusion every third week, 75 mg/m2 according to standard treatment. Patients will be pretreated with prednisolon before infusion with Docetaxel. Continuous treatment with prednisolon will not be administered.
Treatment schedule:
The DC vaccination will be administered once a week in two out of three weeks for the first 12 weeks. After 12 weeks the DC vaccination will be given once every three weeks as long as Docetaxel is given. If the disease does not progress but the patient stop treatment with Docetaxel (because of side effects) the vaccine treatment can continue until disease progression.
Evaluation in details:
Immunological evaluation:
Blood tests:
100 ml blood will be drawn from the patient together with the first (baseline), the third and the fourth infusion of Docetaxel, and every third month thereafter.
DTH:
DTH with 3 i.d. injections consisting of media (neg. test), naked DCs and mRNA transfected DCs will be performed at baseline (together with 1st vaccine), together with the 5th vaccine and after three months of treatment (8th vaccine). 48 hours after the DTH at 5th vaccine a biopsy will be taken from the DTH area.
Clinical evaluation:
PSA:
Patients will be evaluated with PSA measurements during the treatment. All patients will receive at least 4 treatments with Docetaxel even if PSA is rising.
18F-NaF ("bone") PET/CT scan: All patients will have a bone-PET/CT scan at baseline. For patients with measurable lesions a PET/CT scan will be performed every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: mRNA transfected dendritic cell, Drug: DocetaxelDC vaccine (mRNA transfected dendritic cell) + Docetaxel |
| Arm B | Active comparator | Drug: DocetaxelDocetaxel alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological verified CRMPC in progression, defined by
- Treatment with Docetaxel is indicated
- Age > 18 years old
- ECOG performance status ≤2
- Life expectancy > 3 months
Key exclusion criteria (6 listed)
- Other malignant tumors
- Severe heard or lung disorders
- Infection with HIV, hepatitis, tuberculosis.
- Severe allergy or previous anaphylactic reactions
- Active autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA transfected dendritic cellAutologous 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). | Biological | Arm A |
| DocetaxelAlso: taxotereDocetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks). | Drug | Arm A, Arm B |
Primary outcome
Number of Patients With Immunological Response
Time frame: 2 years
The induction of vaccine specific immune responses will be assessed using interferon-gamma ELISPOT assay
3 secondary outcomes
Number of Patients With PSA Response
Time frame: 2 years
Number of Patients With Adverse Event Considered Related to the Dendritic Cell Vaccine
Time frame: 2 years
Progression-free Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Kongsted, MD principal investigator
CCIT / Department of Oncology, Herlev Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mRNA transfected dendritic cell and Docetaxel in people with Prostatic Neoplasms, run by Inge Marie Svane at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Immunological Response (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.