Prostate CancerPhase 1/2NCT01278914
Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer
A Phase 1/2 study testing Dendritic Cells (DC) prostate in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood samples, and adverse events). SECONDARY OBJECTIVES: Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dendritic Cells (DC) prostate
- How many people
- Not given
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2002to Jul 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 45 years of age.
- Must have histologically confirmed adenocarcinoma of the prostate.
- Must have evidence of disease progression while on LHRH agonist, or orchiectomy, with or without an antiandrogen for advanced prostate cancer. All patients will be maintained on the hormone regimen throughout this protocol that they were receiving at the time of entry or recent progression. Increasing PSA in three subsequent analysis.
- Must be ambulatory with a ECOG performance score of <2
- Lab.values as following :ANC ( 1.5 x 109/L; platelets ( 100 x 109/L, Hb ( 9 g/dL (( 5.6 mmol/L). Creatinine ( 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance ( 40 mL/min, Bilirubin < 20% above the upper limit of normal, ASAT and ALAT ( 2.5 the upper limit of normal. Albumin ( 2.5 g/L).
- Prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol.
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- Prior chemotherapy: a minimum of 4 weeks must have elapsed prior to entry in the study.
- If the patient has received strontium-89 and alpha-radin, at least three months must have elapsed prior to entry in the study.
- Informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the ICH-GCP Guidelines.
Who cannot join
- History of prior malignancy other than prostate cancer, clinically evident within the 24 months preceding enrolment into the study, except curatively-treated basal cell or squamous cell carcinoma of the skin.
- Active infection requiring antibiotic therapy.
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- Autoimmune disease treated with steroid(s)
- History of asthma, anaphylaxis or other serious adverse reactions to vaccines.
- History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis/dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
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- Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
- Impending untreated spinal cord compression or urinary outlet obstruction.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer
PRIMARY OBJECTIVES:
Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood samples, and adverse events).
SECONDARY OBJECTIVES:
Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response.
- Conditions
- Prostate Cancer
- Being tested
- Dendritic Cells (DC) prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cells (DC) prostateBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study start1 Feb 2002
- Primary completion10 Aug 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 1/2
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svein Dueland, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278914
- Sponsor's protocol ID
- DC Prostate
- Status last verified
- May 2023
- First submitted
- 17 Jan 2011
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT01278914
- Acronym / sponsor ID
- DC Prostate
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2002 (actual)
- Primary completion
- 10 Aug 2004 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PRIMARY OBJECTIVES:
Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood samples, and adverse events).
SECONDARY OBJECTIVES:
Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response.
Study design
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be at least 45 years of age.
- Must have histologically confirmed adenocarcinoma of the prostate.
- Must have evidence of disease progression while on LHRH agonist, or orchiectomy, with or without an antiandrogen for advanced prostate cancer. All patients will be maintained on the hormone regimen throughout this protocol that they were receiving at the time of entry or recent progression. Increasing PSA in three subsequent analysis.
- Must be ambulatory with a ECOG performance score of <2
- Lab.values as following :ANC ( 1.5 x 109/L; platelets ( 100 x 109/L, Hb ( 9 g/dL (( 5.6 mmol/L). Creatinine ( 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance ( 40 mL/min, Bilirubin < 20% above the upper limit of normal, ASAT and ALAT ( 2.5 the upper limit of normal. Albumin ( 2.5 g/L).
Key exclusion criteria (9 listed)
- History of prior malignancy other than prostate cancer, clinically evident within the 24 months preceding enrolment into the study, except curatively-treated basal cell or squamous cell carcinoma of the skin.
- Active infection requiring antibiotic therapy.
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- Autoimmune disease treated with steroid(s)
- History of asthma, anaphylaxis or other serious adverse reactions to vaccines.
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 |
|---|---|---|
| Dendritic Cells (DC) prostate | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dendritic Cells (DC) prostate in people with Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
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 9 inclusion and 9 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 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 8 May 2023.