Prostatic NeoplasmsPhase 1NCT00096551
A Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer With Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy
A Phase 1 study testing Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM), Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM) and Recombinant Fowlpox-GM-CSF in people with Prostatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer. Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. 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?
- Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM), Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM) and Recombinant Fowlpox-GM-CSF
- Type of treatment
- Vaccines
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2004to 25 Jul 2011
- 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
- Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at: NIH Clinical Center, National Institutes of Health (NIH), the National Naval Medical Center, or Walter Reed Army Medical Center prior to starting this study. If no pathologic specimen is available, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
- Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation or cyrotherapy as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (e.g., three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT.
- Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled.
- Agree to use adequate contraception prior to study entry and for at least 4 months following the last vaccine injection.
- Life expectancy greater than or equal to 6 months.
- ECOG performance status of 0 to 2 (see Appendix A).
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- Recovered from any acute toxicity related to prior therapy, including surgery, and radiation (treatment must have been completed at least 4 weeks prior to being eligible for the study).
- Hematological eligibility parameters (within 16 days of starting therapy, see Appendix D).
- Granulocyte count greater than or equal to 1,500/mm3
- Platelet count greater than or equal to 100,000/mm3
- Lymphocyte count greater than or equal to 500/mm3
- Hgb greater than or equal to 10 Gm/dL
- Biochemical eligibility parameters (within 16 days of starting therapy):
- -A 24-hour urine collection for baseline to measure creatinine clearance, protein and electrolytes. CrCl greater than 60mL/min, proteinuria less than 1000 milligrams per 24 hours, and no abnormal sediment. Serum creatinine not above normal limits OR creatinine clearance on a 24 hour urine collection of greater than 60 mL/min. For patients who are not able to obtain an accurate collection, a calculated creatinine clearance and urine analysis for protein may be used. Any abnormalities in the sediment or the presence of hematuria without a likely underlying cause should prompt the investigator to consider an evaluation by a nephrologist or urologist for evidence of underlying renal pathology.
- Patients may be eligible if the underlying cause of the abnormality is determined to be non-renal.
- -Hepatic function: Bilirubin equal to 1.5 mg/dL or patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL, AST and ALT less than 2.5 times upper limit of normal.
- No other active malignancies within the past 12 months (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses.
- Willing to travel to the NIH for follow-up visits.
- 18 years of age or greater.
- Vaccinia-naive or vaccinia immune.
- Able to understand and sign informed consent.
- Tested for HLA-A2; however, the results of this test will not affect entry into this study. This test may be drawn by the patient's referring physician at the time of referral (see Screening Consent for HLA typing). This consent will be mailed to the patient and discussed with patient. The signed consent will be signed with a non-family member witness and then mailed to the assigned research nurse at the NIH Clinical Center.
- Concurrent hormonal therapy will be allowed.
- PT / PTT will be drawn prior to any invasive protocol related procedure (i.e., prostate biopsy or intraprostatic injection) and standard clinical guidelines followed.
Who cannot join
- Patients should have no evidence of being immunocompromised as listed below.
- Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects.
- Active autoimmune diseases such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome active Grave's disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
- Hepatitis B or C positivity.
- Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Steroid eye drops are contraindicated for at least 2 weeks prior vaccinia vaccination and at least 4 weeks post vaccinia vaccination.
- History of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen.
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- Must be able to avoid close household contact (close household contacts are those who share housing or have close physical contact) for at least three weeks after recombinant vaccinia vaccination with persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.
- Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
- Patients with cardiac disease that have fatigue, palpitation, dyspnea or angina with ordinary physical activity (New York Heart Association class 2 or greater) are not eligible.
- Patients who have objective evidence of congestive heart failure by physical exam or imaging are not eligible.
- Patients with pulmonary disease that have fatigue or dyspnea with ordinary physical activity are not eligible.
- Concurrent chemotherapy.
- Clinically active brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis.
- Serious hypersensitivity reaction to egg products.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer and Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy
Background:
- Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer.
- Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. route of administration, especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c. This may be due to:
- Making the tumor cell an antigen presenting cell via upregulation of both antigen (signal 1) and costimulatory molecules (signal 2).
- Making the tumor cell more susceptible to killing via upregulation of ICAM.
- The increased expression of perforin in peptide-specific T cells that came into contact with the TRICOM-infected targets.
- Potentially allowing the immune system to select for other tumor encoded antigens to generate a polyvalent immune response.
Read more
Objectives:
- 1: Safety and feasibility of an intraprostatic vaccine strategy.
- 2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay.
- 2: To evaluate T-cell infiltration histologically in patients who have pre- and post-vaccine prostate biopsies.
Eligibility:
- Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (eg. three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT.
- Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled.
- Hepatic function: Bilirubin < 1.5 mg/dl, AST and ALT< 2.5 times upper limit of normal
Design:
- Dose escalation Phase I design. Each cohort will consist of 3-6 patients, with cohorts 4 \& 5 restricted to include only HLA-A2 + patients; maximum accrual is 30
- Patients in all cohorts receive initial priming with rV- PSA(L155)/TRICOM and rF-GM-CSF s.c.
- The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSA(L155)/TRICOM.
- Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSA(L155)/TRICOM
- Last (5th) cohort u...
Read the detailed description
Background:
- Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer.
- Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. route of administration, especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c. This may be due to:
- Making the tumor cell an antigen presenting cell via upregulation of both antigen (signal 1) and costimulatory molecules (signal 2).
- Making the tumor cell more susceptible to killing via upregulation of ICAM.
- The increased expression of perforin in peptide-specific T cells that came into contact with the TRICOM-infected targets.
- Potentially allowing the immune system to select for other tumor encoded antigens to generate a polyvalent immune response.
Objectives:
- 1: Safety and feasibility of an intraprostatic vaccine strategy.
- 2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay.
- 2: To evaluate T-cell infiltration histologically in patients who have pre- and post-vaccine prostate biopsies.
Eligibility:
- Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (eg. three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT.
- Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled.
- Hepatic function: Bilirubin less than 1.5 mg/dl, AST and ALT less than 2.5 times upper limit of normal.
Design:
- Dose escalation Phase I design. Each cohort will consist of 3-6 patients; maximum accrual is 30
- Patients in all cohorts receive initial priming with rV- PSA(L155)/TRICOM and rF-GM-CSF s.c.
- The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSA(L155)/TRICOM.
- Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSA(L155)/TRICOM.
- Last (5th) cohort utilizes booster intraprostatic vaccine (rF-PSA(L155)/TRICOM and rF-GM-CSF) with simultaneous identical booster vaccine given s.c.
- Conditions
- Prostatic Neoplasms
- Being tested
- Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM), Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM), Recombinant Fowlpox-GM-CSF
- Keywords
- Biochemical Failure, Immunotherapy, TRICOM, Pox-virus, Fowlpox, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Fowlpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM)Drug
Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM)Drug
Recombinant Fowlpox-GM-CSFDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
1 Nov 200425 Jul 2011
- First posted10 Nov 2004 (estimated)
- Study start1 Nov 2004
- Primary completion11 Dec 2009
- Study completion25 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Primary purpose
- Treatment
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096551
- Sponsor's protocol ID
- 050017
- Other IDs
- 05-C-0017
- Status last verified
- 25 Jul 2011
- First submitted
- 7 Jul 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Lattouf JB, Arlen PM, Pinto PA, Gulley JL. A phase I feasibility study of an intraprostatic prostate-specific antigen-based vaccine in patients with prostate cancer with local failure after radiation therapy or clinical progression on androgen-deprivation therapy in the absence of local definitive therapy. Clin Genitourin Cancer. 2006 Jun;5(1):89-92. doi: 10.3816/CGC.2006.n.024. No abstract available.
PubMed 16859586Kudo-Saito C, Schlom J, Hodge JW. Intratumoral vaccination and diversified subcutaneous/ intratumoral vaccination with recombinant poxviruses encoding a tumor antigen and multiple costimulatory molecules. Clin Cancer Res. 2004 Feb 1;10(3):1090-9. doi: 10.1158/1078-0432.ccr-03-0145.
PubMed 14871989
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Feasibility Study of an Intraprostatic PSA-Based Vaccine in Men With Prostate Cancer and Local Failure Following Radiotherapy or Cryotherapy or Clinical Progression on Androgen Deprivation Therapy in the Absence of Local Definitive Therapy
- ClinicalTrials.gov ID
- NCT00096551
- Acronym / sponsor ID
- 050017
- Conditions
- Prostatic Neoplasms
- Keywords
- Biochemical Failure, Immunotherapy, TRICOM, Pox-virus, Fowlpox, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Nov 2004
- Primary completion
- 11 Dec 2009 (actual)
- Study completion
- 25 Jul 2011 (actual)
- First posted
- 10 Nov 2004 (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.
Background:
- Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer.
- Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. route of administration, especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c. This may be due to:
- Making the tumor cell an antigen presenting cell via upregulation of both antigen (signal 1) and costimulatory molecules (signal 2).
- Making the tumor cell more susceptible to killing via upregulation of ICAM.
- The increased expression of perforin in peptide-specific T cells that came into contact with the TRICOM-infected targets.
- Potentially allowing the immune system to select for other tumor encoded antigens to generate a polyvalent immune response.
Objectives:
- 1: Safety and feasibility of an intraprostatic vaccine strategy.
- 2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay.
- 2: To evaluate T-cell infiltration histologically in patients who have pre- and post-vaccine prostate biopsies.
Eligibility:
- Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (eg. three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT.
- Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled.
- Hepatic function: Bilirubin < 1.5 mg/dl, AST and ALT< 2.5 times upper limit of normal
Design:
- Dose escalation Phase I design. Each cohort will consist of 3-6 patients, with cohorts 4 \& 5 restricted to include only HLA-A2 + patients; maximum accrual is 30
- Patients in all cohorts receive initial priming with rV- PSA(L155)/TRICOM and rF-GM-CSF s.c.
- The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSA(L155)/TRICOM.
- Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSA(L155)/TRICOM
- Last (5th) cohort u...
Detailed description
Background:
- Pox viral vectors can induce a PSA-specific T-cell responses and clinical responses in patients with advanced prostate cancer.
- Intratumoral vaccines of recombinant fowlpox vectors appear to be more potent in inducing antitumor effects than the s.c. route of administration, especially when the recombinant rF-vector given intratumorally is preceded by a rV-recombinant given s.c. This may be due to:
- Making the tumor cell an antigen presenting cell via upregulation of both antigen (signal 1) and costimulatory molecules (signal 2).
- Making the tumor cell more susceptible to killing via upregulation of ICAM.
- The increased expression of perforin in peptide-specific T cells that came into contact with the TRICOM-infected targets.
- Potentially allowing the immune system to select for other tumor encoded antigens to generate a polyvalent immune response.
Objectives:
- 1: Safety and feasibility of an intraprostatic vaccine strategy.
- 2: To assess the change in PSA-specific T-cell response as measured by ELISPOT assay.
- 2: To evaluate T-cell infiltration histologically in patients who have pre- and post-vaccine prostate biopsies.
Eligibility:
- Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (eg. three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT.
- Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled.
- Hepatic function: Bilirubin less than 1.5 mg/dl, AST and ALT less than 2.5 times upper limit of normal.
Design:
- Dose escalation Phase I design. Each cohort will consist of 3-6 patients; maximum accrual is 30
- Patients in all cohorts receive initial priming with rV- PSA(L155)/TRICOM and rF-GM-CSF s.c.
- The first two cohorts utilize a booster intraprostatic with dose escalation of rF-PSA(L155)/TRICOM.
- Third and fourth cohorts add dose escalations of rF-GM-CSF along with the highest dose of rF-PSA(L155)/TRICOM.
- Last (5th) cohort utilizes booster intraprostatic vaccine (rF-PSA(L155)/TRICOM and rF-GM-CSF) with simultaneous identical booster vaccine given s.c.
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 (24 listed)
- Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at: NIH Clinical Center, National Institutes of Health (NIH), the National Naval Medical Center, or Walter Reed Army Medical Center prior to starting this study. If no pathologic specimen is available, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
- Must have either a) biopsy proven, locally recurrent prostate cancer following local radiation or cyrotherapy as defined by the ASTRO consensus criteria as 3 consecutively rising PSA levels or b) have refused or not be candidates for local definitive therapy (surgery or radiation therapy) and have clinically progressive disease on androgen deprivation therapy (e.g., three increases in PSA over nadir, separated by at least one week). For patients with previous RT, the biopsy confirming local recurrence must be done at least 18 months after the completion of RT.
- Since this may also generate a systemic immune response, patients with minimal extraprostatic disease may be enrolled.
- Agree to use adequate contraception prior to study entry and for at least 4 months following the last vaccine injection.
- Life expectancy greater than or equal to 6 months.
Key exclusion criteria (14 listed)
- Patients should have no evidence of being immunocompromised as listed below.
- Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects.
- Active autoimmune diseases such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome active Grave's disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
- Hepatitis B or C positivity.
- Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Steroid eye drops are contraindicated for at least 2 weeks prior vaccinia vaccination and at least 4 weeks post vaccinia vaccination.
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 |
|---|---|---|
| Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM) | Drug | – |
| Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM) | Drug | – |
| Recombinant Fowlpox-GM-CSF | Drug | – |
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 2 Jul 2017.
- Background: PubMed 16859586Lattouf JB, Arlen PM, Pinto PA, Gulley JL. A phase I feasibility study of an intraprostatic prostate-specific antigen-based vaccine in patients with prostate cancer with local failure after radiation therapy or clinical progression on androgen-deprivation therapy in the absence of local definitive therapy. Clin Genitourin Cancer. 2006 Jun;5(1):89-92. doi: 10.3816/CGC.2006.n.024. No abstract available.
- Background: PubMed 14871989Kudo-Saito C, Schlom J, Hodge JW. Intratumoral vaccination and diversified subcutaneous/ intratumoral vaccination with recombinant poxviruses encoding a tumor antigen and multiple costimulatory molecules. Clin Cancer Res. 2004 Feb 1;10(3):1090-9. doi: 10.1158/1078-0432.ccr-03-0145.
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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 Recombinant Vaccinia-PSA(L155)/TRICOM (PROSTVAC-V/TRICOM), Recombinant Fowlpox-PSA(L155)/TRICOM (PROSTVAC-F/TRICOM) and Recombinant Fowlpox-GM-CSF in people with Prostatic Neoplasms, run by National Cancer Institute (NCI) 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 24 inclusion and 14 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 2 Jul 2017. 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?
On the ClinicalTrials.gov record for NCT00096551, which also lists 2 linked publications.
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 2 Jul 2017.