Prostate CancerPhase 1NCT00108264
Tumor RNA Transfected Dendritic Cell Vaccines
A Phase 1 study testing Tumor RNA transfected dendritic cells in people with Prostate Cancer, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to use dendritic cells transfected with amplified RNA from autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in patients with disseminated disease. Read more about this study
- Who is it for?
- Ages 10 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Tumor RNA transfected dendritic cells
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2005
- Phase
- Phase 1
- 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 10 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a histologically confirmed diagnosis of metastatic prostate cancer stages D1 - D3 are eligible for this study.
- They must not have a history of autoimmune disease, serious intercurrent chronic or acute illness, pulmonary disease, active hepatitis, serologic evidence for HIV, or be receiving corticosteroid or immunosuppressive therapy.
Who cannot join
- Patients will be excluded from the study if they have received chemotherapy or other forms of immunotherapy in the 6 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to use dendritic cells transfected with amplified RNA from autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in patients with disseminated disease.
Read the detailed description
The specific aims are: 1) to evaluate, in a phase I clinical trial, the safety of vaccinating patients with dendritic cells transfected with RNA from autologous cancer cells; 2) to analyze the T cell responses induced by the treatment; and 3) to improve the efficacy of the treatment by developing methods to increase the induction of CD4+T cell responses.
- Conditions
- Prostate Cancer
- Being tested
- Tumor RNA transfected dendritic cells
- Keywords
- Prostatic Neoplasms, Neoplasm Metastasis, Immunotherapy, Active, Dendritic Cells
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor RNA transfected dendritic cellsBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study completionSep 2005
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.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108264
- Sponsor's protocol ID
- CLIN-021-02S
- Status last verified
- May 2007
- First submitted
- 14 Apr 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor RNA Transfected Dendritic Cell Vaccines
- ClinicalTrials.gov ID
- NCT00108264
- Acronym / sponsor ID
- CLIN-021-02S
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Neoplasms, Neoplasm Metastasis, Immunotherapy, Active, Dendritic Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2005
- First posted
- 15 Apr 2005 (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.
The purpose of this study is to use dendritic cells transfected with amplified RNA from autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in patients with disseminated disease.
Detailed description
The specific aims are: 1) to evaluate, in a phase I clinical trial, the safety of vaccinating patients with dendritic cells transfected with RNA from autologous cancer cells; 2) to analyze the T cell responses induced by the treatment; and 3) to improve the efficacy of the treatment by developing methods to increase the induction of CD4+T cell responses.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a histologically confirmed diagnosis of metastatic prostate cancer stages D1 - D3 are eligible for this study.
- They must not have a history of autoimmune disease, serious intercurrent chronic or acute illness, pulmonary disease, active hepatitis, serologic evidence for HIV, or be receiving corticosteroid or immunosuppressive therapy.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they have received chemotherapy or other forms of immunotherapy in the 6 weeks prior to study entry.
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 |
|---|---|---|
| Tumor RNA transfected dendritic cells | 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 21 Jan 2009.
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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 study testing Tumor RNA transfected dendritic cells in people with Prostate Cancer, run by US Department of Veterans Affairs at 1 site in United States.
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 2 inclusion and 1 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 21 Jan 2009. 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 United States. 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 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.
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 21 Jan 2009.