Prostate CancerPhase 1NCT00006430
A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA
A Phase 1 study testing Autologous dendritic cells transfected with amplified tumor RNA in people with Prostate Cancer, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
Purpose: This protocol proposes a safety and feasibility trial in patients with metastatic prostate cancer (stages D1-D3) investigating the induction of antitumor immunity by administration of cultured autologous peripheral blood precursor derived dendritic cells (DC), transfected with mRNA amplified from autologous… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Autologous dendritic cells transfected with amplified tumor RNA
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has a histologic or clinically confirmed prostate adenocarcinoma (Stage D1-D3 metastatic with regional lymphatic, bone, visceral, or soft tissue metastases). (Transitional cell and small cell carcinomas of prostate origin are excluded.)
- The patient has a karnofsky performance status greater than or equal to 70%.
- Estimated life expectancy > 6 months
- The patient has adequate hematologic function with: WBC>=3000mm3, Hemoglobin>=9mg/dl, Platelets>=100,000/mm3
- The patient has adequate renal and hepatic function with: serum creatinine < 2.5mg/dl bilirubin < 2.0 mg/dl
- The patient has adequate coagulation parameters with: PT = 11.3-13.3 sec PTT = 20.1-32.9 sec
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- For patients who receive medical gonadal androgen suppression, the patient may continue hormonally ablative therapy with LHRH analogues only (i.e. Gosereline or Leuprolide). Testosterone level must be <50 mg/l.
- For patients who receive oral nonsteroidal antiandrogen therapy (i.e.flutamide or bicalutamide) and experience a rising PSA: a 4 week period of observation must be completed following discontinuation of the nonsteroidal antiandrogen prior to entry.
- The patient has the ability to understand and provide signed inform consent that fulfills Institutional Review Board guidelines.
- The patient has the ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
Who cannot join
- The patient is receiving concurrent chemotherapy, radiation therapy, or immunotherapy. There must be at least 4 weeks (12 weeks if prior therapy included 89-Strontium) between any prior therapy and study entry. Patients must have recovered from all acute toxicities from prior treatment.
- The patient has previously irradiated or new CNS (central nervous system) metastases. (Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.)
- The patient has a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- The patient has a serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
- The patient has a serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
- The patient has a medical or psychological impediment to probable compliance with the protocol.
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- The patient has a concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer.
- The patient has an active acute or chronic infection, including symptomatic urinary tract infection, HIV, or viral hepatitis.
- The patient is receiving oral or steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A). There must be 6 weeks between discontinuation of any steroid therapy and study enrollment.
- The patient has inadequate peripheral vein access to perform leukapheresis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Purpose: This protocol proposes a safety and feasibility trial in patients with metastatic prostate cancer (stages D1-D3) investigating the induction of antitumor immunity by administration of cultured autologous peripheral blood precursor derived dendritic cells (DC), transfected with mRNA amplified from autologous prostate tumor tissue. The feasibility and dose-limiting toxicity of administering escalating doses of tumor RNA transfected dendritic cells will be defined. As a secondary endpoint, the ability of tumor RNA transfected dendritic cells to induce tumor-specific immune responses will be evaluated. Finally, the anti-tumor effect based on PSA (biochemical) response criteria will be defined.
Background: Because prostate cancer is incurable when metastatic and conventional therapies do not offer a clear survival benefit, new therapeutic strategies are warranted. This study is based on the premise that clinically effective cell mediated immune responses against prostate tumors can be elicited by activation of tumor associated antigen specific T cells. Work performed by others and our group suggests that PSA, a protein expressed in virtually all prostate cancers, can serve as a widely expressed candidate antigen for prostate cancer immunotherapy. In particular, we have shown that cultured dendritic cells transfected with mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro. Therefore, we hypothesize that administration of PSA RNA transfected DC will lead to detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing metastatic prostate cancer. It is hoped that these T cell responses also have clinical antitumor activity.
Read the detailed description
Methods: Patients will undergo percutaneous needle biopsies from either primary or metastatic sites to obtain tumor tissue. Patients in whom sufficient tumor mRNA has been amplified by PCR to transfect the assigned dendritic cell dose will undergo leukapheresis and peripheral blood mononuclear cells will be cultured in vitro for 7 days with GM-CSF and IL-4 to generate precursor derived dendritic cells. Dendritic cells will then be cryopreserved for later use. On the day the patient returns to receive his infusion (weeks 0, 2, and 4) the dendritic cells will be thawed, reconstituted, and transfected with amplified total tumor mRNA. Patients will receive a total of 3 treatments consisting of combined I.V. and I.D. injections, each on study week 0, 2, and 4. Repeat leukapheresis will be performed 2 weeks after the last dose to determine immune function. PSA levels will be measured prior to the start of treatment and 2 weeks following the last infusion. Patients who do not receive therapy due to a failure to produce sufficient RNA or dendritic cells will be replaced in order to assess toxicity.
Data Analysis: 1. To determine the short and long term toxicities associated with administration of tumor RNA dendritic cells in patients with metastatic prostate cancer. 2. To determine feasibility of dendritic cell vaccine generation according to the proportion of patients for whom sufficient cells are generated to provide treatment. 3. To determine the cellular immune response to intravenous infusion of tumor RNA dendritic cells. 4. To measure the PSA response of patients with metastatic prostate cancer to intravenous infusion of tumor RNA dendritic cells.
- Conditions
- Prostate Cancer
- Being tested
- Autologous dendritic cells transfected with amplified tumor RNA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dendritic cells transfected with amplified tumor RNABiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2000 (estimated)
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
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Duke University
- Investigators
- Johannes Vieweg, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006430
- Sponsor's protocol ID
- NCRR-M01RR00030-0177
- Other IDs
- M01RR000030
- Status last verified
- Feb 2002
- First submitted
- 3 Nov 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA
- ClinicalTrials.gov ID
- NCT00006430
- Acronym / sponsor ID
- NCRR-M01RR00030-0177
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Duke University
- First posted
- 6 Nov 2000 (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.
Purpose: This protocol proposes a safety and feasibility trial in patients with metastatic prostate cancer (stages D1-D3) investigating the induction of antitumor immunity by administration of cultured autologous peripheral blood precursor derived dendritic cells (DC), transfected with mRNA amplified from autologous prostate tumor tissue. The feasibility and dose-limiting toxicity of administering escalating doses of tumor RNA transfected dendritic cells will be defined. As a secondary endpoint, the ability of tumor RNA transfected dendritic cells to induce tumor-specific immune responses will be evaluated. Finally, the anti-tumor effect based on PSA (biochemical) response criteria will be defined.
Background: Because prostate cancer is incurable when metastatic and conventional therapies do not offer a clear survival benefit, new therapeutic strategies are warranted. This study is based on the premise that clinically effective cell mediated immune responses against prostate tumors can be elicited by activation of tumor associated antigen specific T cells. Work performed by others and our group suggests that PSA, a protein expressed in virtually all prostate cancers, can serve as a widely expressed candidate antigen for prostate cancer immunotherapy. In particular, we have shown that cultured dendritic cells transfected with mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro. Therefore, we hypothesize that administration of PSA RNA transfected DC will lead to detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing metastatic prostate cancer. It is hoped that these T cell responses also have clinical antitumor activity.
Detailed description
Methods: Patients will undergo percutaneous needle biopsies from either primary or metastatic sites to obtain tumor tissue. Patients in whom sufficient tumor mRNA has been amplified by PCR to transfect the assigned dendritic cell dose will undergo leukapheresis and peripheral blood mononuclear cells will be cultured in vitro for 7 days with GM-CSF and IL-4 to generate precursor derived dendritic cells. Dendritic cells will then be cryopreserved for later use. On the day the patient returns to receive his infusion (weeks 0, 2, and 4) the dendritic cells will be thawed, reconstituted, and transfected with amplified total tumor mRNA. Patients will receive a total of 3 treatments consisting of combined I.V. and I.D. injections, each on study week 0, 2, and 4. Repeat leukapheresis will be performed 2 weeks after the last dose to determine immune function. PSA levels will be measured prior to the start of treatment and 2 weeks following the last infusion. Patients who do not receive therapy due to a failure to produce sufficient RNA or dendritic cells will be replaced in order to assess toxicity.
Data Analysis: 1. To determine the short and long term toxicities associated with administration of tumor RNA dendritic cells in patients with metastatic prostate cancer. 2. To determine feasibility of dendritic cell vaccine generation according to the proportion of patients for whom sufficient cells are generated to provide treatment. 3. To determine the cellular immune response to intravenous infusion of tumor RNA dendritic cells. 4. To measure the PSA response of patients with metastatic prostate cancer to intravenous infusion of tumor RNA dendritic cells.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient has a histologic or clinically confirmed prostate adenocarcinoma (Stage D1-D3 metastatic with regional lymphatic, bone, visceral, or soft tissue metastases). (Transitional cell and small cell carcinomas of prostate origin are excluded.)
- The patient has a karnofsky performance status greater than or equal to 70%.
- Estimated life expectancy > 6 months
- The patient has adequate hematologic function with: WBC>=3000mm3, Hemoglobin>=9mg/dl, Platelets>=100,000/mm3
- The patient has adequate renal and hepatic function with: serum creatinine < 2.5mg/dl bilirubin < 2.0 mg/dl
Key exclusion criteria (10 listed)
- The patient is receiving concurrent chemotherapy, radiation therapy, or immunotherapy. There must be at least 4 weeks (12 weeks if prior therapy included 89-Strontium) between any prior therapy and study entry. Patients must have recovered from all acute toxicities from prior treatment.
- The patient has previously irradiated or new CNS (central nervous system) metastases. (Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.)
- The patient has a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- The patient has a serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
- The patient has a serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
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 |
|---|---|---|
| Autologous dendritic cells transfected with amplified tumor RNA | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Johannes Vieweg, M.D. principal investigator
Duke University
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 Autologous dendritic cells transfected with amplified tumor RNA in people with Prostate Cancer, run by National Center for Research Resources (NCRR) 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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?
Results are not available in the source record.
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 24 Jun 2005.