Prostate CancerPhase 1PSANCT02058680
Phase 1A/1B Study of PSA/IL-2/GM-CSF Vaccine for Recurrent Prostate Cancer in Hormone Naive and Hormone Independent Patients
A Phase 1 study testing PSA/IL-2/GM-CSF in people with Prostate Cancer, run by OncBioMune Pharmaceuticals at 1 site in United States.
Trial summary
This study is investigating the safety and efficacy of a vaccine directed against prostate tumor cells. The researchers are interested in evaluating the safety and tolerability of the vaccine, and the effects of the vaccine on survivability, time to measurable disease, prostate-specific antigen (PSA) level in the… 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?
- PSA/IL-2/GM-CSF
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2018
- 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
- Histologically confirmed adenocarcinoma of the prostate
- Age greater than18 years
- Rising serum PSA levels documented by 3 values over the last 6 months prior to study enrollment. Each value must be greater than 2 weeks from the previous value.
- Patients with rising PSA must have had either 1) prior definitive therapy including surgery or radiation therapy (hormone-naïve, defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone greater than 50 ng/dL), or 2) hormone suppressive therapy as documented by surgical castration or a serum testosterone value less than 50 ng/dL (hormone-independent). Patients must have completed these therapies for at least 6 months but no longer than 20 years prior to enrollment
- PSA value within 4 weeks of starting therapy less than 20 ng/mL for hormone-naïve patients (defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone greater than 50 ng/dL) or less than 60 ng/mL for hormone-independent patients.
- Patients must have the following laboratory values: ANC greater than 1500/mcL, platelet count greater than 100,000/mcL, hemoglobin greater than 10 g/dL, bilirubin less than 1.5 x upper limits of normal, AST less than 1.5 x upper limits of normal
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- Patients must have adequate lung function, as defined by oxygen saturation greater than or equal to 90% by pulse oximetry
- Patients must have QTc interval less than 450 msec
- Patients must have adequate EGFR greater than 30 mL/min per 1.73 m2 (per VA formula and adjusted for gender and race)
- Patients with female partners of childbearing potential must use at least one form of Investigator-approved contraception while on-study and for 30 days after their last administration of study investigational therapy. Acceptable birth control options include: a) surgical sterilization (subject and/or subject's partner), b) approved hormonal contraceptives or therapies (such as birth control pills, Depo-Provera, or Lupron Depot), c) barrier methods (such as a condom or diaphragm) used with a spermicide, and d) an intrauterine device (IUD).
Who cannot join
- Presence of documented neuroendocrine differentiation on the original pathology report
- Evidence of metastatic disease
- Immune compromised patients including but not limited to: systemic immune suppressive medications within 6 weeks of enrolling; HIV-positive and below normal CD4 lymphocytes (less than 500 cells per microliter). Patients must be tested for HIV seropositivity and CD4 lymphocyte count to be eligible for the study
- Prior malignancy. Patients with nonmelanoma skin cancer or other cancers with greater than 3 years without evidence of disease recurrence are eligible
- Inability to give informed consent
- Any condition that, according to the investigator, would make the patient an inappropriate study candidate.
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- Patients with pulmonary disease limiting daily function or requiring oxygen supplementation
- Patients with significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within six months of study entry, uncontrolled dysrhythmias, or QTc greater than or equal to 450 msec
- Patients with existing autoimmune disorders (IL-2 and GM-CSF carry a theoretical clinical risk of exacerbating underlying autoimmune disorders)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: A Phase 1A/1B, Two-Stage Study of a PSA/IL-2/GM-CSF Vaccine for the Treatment of PSA Recurrent Prostate Cancer in Hormone-Naive and Hormone-Independent Patients
This study is investigating the safety and efficacy of a vaccine directed against prostate tumor cells. The researchers are interested in evaluating the safety and tolerability of the vaccine, and the effects of the vaccine on survivability, time to measurable disease, prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine.
Eligible patients include those with recurrent prostate cancer as shown by elevated levels of PSA, although there is no evidence of tumors that are measurable by imaging studies. In addition, to be eligible patients must have prostate cancer that either has not been treated by hormonal therapy or is not responsive to hormonal therapy.
Read the detailed description
In Phase 1A, hormone naive and hormone independent patients are enrolled in a 1:1 ratio. All patients receive intradermal injections of the PSA/IL-2/GM-CSF induction vaccine at Weeks 1, 2, 3, 7, 11 and 15.
In Phase 1B, which will be initiated after Phase 1A, will first receive the induction vaccine (PSA/IL-2/GM-CSF) according to the same schedule as patients in Phase 1A. Then, in eligible Phase 1B patients, following the induction vaccine regimen, alternating maintenance vaccination will be administered as follows: at Weeks 23, 31, and 39, IL-2 alone will be administered; at Weeks 27, 35, and 43, the complete vaccine (PSA/IL-2/GM-CSF) will be administered.
- Conditions
- Prostate Cancer
- Being tested
- PSA/IL-2/GM-CSF
- Keywords
- prostate specific antigen (PSA)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA/IL-2/GM-CSFBiological
In Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15.
In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43.
| Study group | Role | What they receive |
|---|---|---|
| PSA/IL-2/GM-CSF vaccine | Experimental | In Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15.
In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43. Receives: Biological: PSA/IL-2/GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Adverse Events
Measured: From first injection until 30 days past the last injection
Secondary outcomes (5)
PSA Doubling Time (PSADT) and PAP levels
Measured: Measured at pretreatment screening, prior to first vaccine injection, and then following vaccination at treatment Weeks 7, 15, 19 (Phase 1A), and then every 12 weeks up to Week 103 (Phase 1B).
Time to measurable disease
Measured: Time to confirmation of disease recurrence. Patients undergo bone scans and CT scans of chest, abdomen, and pelvis at pretreatment and then at Week 19, and every 24 weeks (6 months) until Week 105.
Time to subsequent therapy
Measured: Time (days) from Day 1 (first day of vaccine treatment) to either the next investigational anticancer treatment or the first supplemental palliative treatment, up to Week 105.
Overall survival
Measured: Time (days) from Day 1 to the patient's death. Patients will be followed up to Week 105.
Vaccine-induced immune response including antiPSA antibodies, lymphocyte activation assays, and serum and intracellular cytokine levels
Measured: Measured at pretreatment screening or Day 1 pre-vaccination, and then treatment Weeks 7 and 19, and then every 12 weeks up to Week 103
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncBioMune Pharmaceuticals
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Jessica Wang-Rodriguez, MD, Principal investigator, University of California, San DiegoGregory A Daniels, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058680
- Sponsor's protocol ID
- O11-10678
- Other IDs
- Department of Defense
- Acronym
- PSA
- Status last verified
- Sep 2018
- First submitted
- 4 Feb 2014
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1A/1B, Two-Stage Study of a PSA/IL-2/GM-CSF Vaccine for the Treatment of PSA Recurrent Prostate Cancer in Hormone-Naive and Hormone-Independent Patients
- ClinicalTrials.gov ID
- NCT02058680
- Acronym / sponsor ID
- PSA / O11-10678
- Conditions
- Prostate Cancer
- Keywords
- prostate specific antigen (PSA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- OncBioMune PharmaceuticalsUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Apr 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Feb 2014 (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.
This study is investigating the safety and efficacy of a vaccine directed against prostate tumor cells. The researchers are interested in evaluating the safety and tolerability of the vaccine, and the effects of the vaccine on survivability, time to measurable disease, prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine.
Eligible patients include those with recurrent prostate cancer as shown by elevated levels of PSA, although there is no evidence of tumors that are measurable by imaging studies. In addition, to be eligible patients must have prostate cancer that either has not been treated by hormonal therapy or is not responsive to hormonal therapy.
Detailed description
In Phase 1A, hormone naive and hormone independent patients are enrolled in a 1:1 ratio. All patients receive intradermal injections of the PSA/IL-2/GM-CSF induction vaccine at Weeks 1, 2, 3, 7, 11 and 15.
In Phase 1B, which will be initiated after Phase 1A, will first receive the induction vaccine (PSA/IL-2/GM-CSF) according to the same schedule as patients in Phase 1A. Then, in eligible Phase 1B patients, following the induction vaccine regimen, alternating maintenance vaccination will be administered as follows: at Weeks 23, 31, and 39, IL-2 alone will be administered; at Weeks 27, 35, and 43, the complete vaccine (PSA/IL-2/GM-CSF) will be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSA/IL-2/GM-CSF vaccine | Experimental | Biological: PSA/IL-2/GM-CSFIn Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15. In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43. |
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)
- Histologically confirmed adenocarcinoma of the prostate
- Age greater than18 years
- Rising serum PSA levels documented by 3 values over the last 6 months prior to study enrollment. Each value must be greater than 2 weeks from the previous value.
- Patients with rising PSA must have had either 1) prior definitive therapy including surgery or radiation therapy (hormone-naïve, defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone greater than 50 ng/dL), or 2) hormone suppressive therapy as documented by surgical castration or a serum testosterone value less than 50 ng/dL (hormone-independent). Patients must have completed these therapies for at least 6 months but no longer than 20 years prior to enrollment
- PSA value within 4 weeks of starting therapy less than 20 ng/mL for hormone-naïve patients (defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone greater than 50 ng/dL) or less than 60 ng/mL for hormone-independent patients.
Key exclusion criteria (9 listed)
- Presence of documented neuroendocrine differentiation on the original pathology report
- Evidence of metastatic disease
- Immune compromised patients including but not limited to: systemic immune suppressive medications within 6 weeks of enrolling; HIV-positive and below normal CD4 lymphocytes (less than 500 cells per microliter). Patients must be tested for HIV seropositivity and CD4 lymphocyte count to be eligible for the study
- Prior malignancy. Patients with nonmelanoma skin cancer or other cancers with greater than 3 years without evidence of disease recurrence are eligible
- Inability to give informed consent
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 |
|---|---|---|
| PSA/IL-2/GM-CSFIn Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15. In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43. | Biological | PSA/IL-2/GM-CSF vaccine |
Primary outcome
Dose Limiting Adverse Events
Time frame: From first injection until 30 days past the last injection
5 secondary outcomes
PSA Doubling Time (PSADT) and PAP levels
Time frame: Measured at pretreatment screening, prior to first vaccine injection, and then following vaccination at treatment Weeks 7, 15, 19 (Phase 1A), and then every 12 weeks up to Week 103 (Phase 1B).
Time to measurable disease
Time frame: Time to confirmation of disease recurrence. Patients undergo bone scans and CT scans of chest, abdomen, and pelvis at pretreatment and then at Week 19, and every 24 weeks (6 months) until Week 105.
Time to subsequent therapy
Time frame: Time (days) from Day 1 (first day of vaccine treatment) to either the next investigational anticancer treatment or the first supplemental palliative treatment, up to Week 105.
Overall survival
Time frame: Time (days) from Day 1 to the patient's death. Patients will be followed up to Week 105.
Vaccine-induced immune response including antiPSA antibodies, lymphocyte activation assays, and serum and intracellular cytokine levels
Time frame: Measured at pretreatment screening or Day 1 pre-vaccination, and then treatment Weeks 7 and 19, and then every 12 weeks up to Week 103
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
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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.
Jessica Wang-Rodriguez, MD principal investigator
University of California, San Diego
Gregory A Daniels, MD, PhD principal investigator
University of California, San Diego
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 PSA/IL-2/GM-CSF in people with Prostate Cancer, run by OncBioMune Pharmaceuticals 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 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: status not confirmed, as of the sponsor's last update on 10 Sep 2018. 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.
What does the primary outcome measure?
Dose Limiting Adverse Events (time frame: From first injection until 30 days past the last injection). 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 10 Sep 2018.