Prostatic NeoplasmsPhase 1NCT00110526
Gene Therapy for Prostate Cancer That Returns After Radiation Therapy
A Phase 1 study testing Ad.hIL-12 in people with Prostatic Neoplasms and Neoplasm Recurrence, Local, run by Simon Hall.
Trial summary
The purpose of this research study is to test a new treatment for prostate cancer. We have been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a virus which produces a cytokine called interleukin-12 (IL-12) into the prostate gland to control tumor growth. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Neoplasm Recurrence, Local
- What is being tested?
- Ad.hIL-12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Apr 2008
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A local recurrence of prostate cancer (in or next to gland) following treatment by radiation therapy (either external beam or seed implantation)
- Rising PSA (Prostate Specific Antigen) on at least three occasions separated by two weeks
- Ultrasound guided biopsy to diagnose recurrent disease within the prostate
- No evidence of prostate cancer that has spread on bone scan or Computed Tomography (CT) scan
- No hormone therapy at time of enrollment to the research study
Who cannot join
- Radical prostatectomy for treatment of prostate cancer
- Detectable spread of prostate cancer on bone or CT scan
- Immunosuppressive medication within two months of the study
- Acute infection (any bacterial, viral, fungal infection requiring specific therapy)
- HIV disease
- Other significant medical or psychiatric conditions which pose high risk for an investigational study
About this study
Official title: Phase I Trial of Adenovirus- Mediated IL-12 Gene Transduction in Patients With Radiorecurrent Prostate Cancer
The purpose of this research study is to test a new treatment for prostate cancer. We have been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a virus which produces a cytokine called interleukin-12 (IL-12) into the prostate gland to control tumor growth. We propose to explore the use of adenovirus-mediated human interleukin-12 (Ad.hIL-12) in patients with recurrent non-metastatic prostate cancer following radiation therapy in a Phase I trial. Participants will be placed in rising dose groups with the primary endpoint of learning the maximum dose that can safely be given by injection directly into the prostate gland. Toxicity will be determined through physical examination, laboratory values, and blood levels of cytokines. Evidence of an immune response against prostate proteins will also be monitored. If the treatment works, the cancer will shrink or not grow. This will be monitored by prostate specific antigen (PSA) levels in the blood. However, we do not know if this treatment will be effective. If the PSA continues to rise after treatment, participants will be taken off study and offered other treatment. There is no compensation for participation in this research study. There will be no charge for the treatment with gene therapy or the monitoring associated with this research study. Monitoring will occur in a specially designated clinical research center.
Read the detailed description
Patients with radiorecurrent prostate cancer have few viable treatment options, both in terms of efficacy and morbidity. Local therapies fail even in highly selected patients due to locally advanced disease, microscopic metastases, and a worsening of the biology of cancer cells. Furthermore, attempts at salvage local treatments have the complications of incontinence, impotence and in some cases unremitting penile pain. Pre-clinical studies in a mouse model of prostate cancer have noted the potential benefit of adenovirus-mediated gene therapy to deliver IL-12 in this clinical scenario. This treatment was able to significantly growth suppress the injected tumor to prolong survival and reduce the number of pre-established metastases. The mechanisms underlying this activity involved both innate immunity (neutrophils and natural killer [NK] cells) and acquired immunity ( T cells) and enhanced expression of Fas to further sensitize Fas/Fas ligand (FasL) killing.
This is a Phase I study. Therefore, the primary objective is finding the Maximum Tolerated Dose. Within this realm will be monitoring of pro-inflammatory cytokines. Secondary aspects will involve correlating important mechanisms identified in the pre-clinical model: induction of T cells.
- Conditions
- Prostatic Neoplasms, Neoplasm Recurrence, Local
- Being tested
- Ad.hIL-12
- Keywords
- Prostate Cancer, Radiation Therapy, Local recurrence, Gene Therapy
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad.hIL-12Genetic
Ad.hIL-12 intraprostatic injection IND
| Study group | Role | What they receive |
|---|---|---|
| Ad.hIL-12 | Experimental | Not described Receives: Genetic: Ad.hIL-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum cytokine gene therapy level
To study in a Phase I clinical trial the safety of intraprostatic injection of a replication incompetent adenovirus expressing hIL-12 in patients with radiorecurrent prostate cancer
Measured: after 56 weeks, every 6 months up to 15 years
Secondary outcomes (10)
serum pro-inflammatory cytokines levels
To assess serum levels of pro-inflammatory cytokines before and after vector injection and will continue every 3 days until normalized
Measured: up to 15 years
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Day 7,14,21 and 28 post vector injection
Measured: Day 7 post vector injection
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Day 7,14,21 and 28 post vector injection
Measured: Day 14 post vector injection
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Day 7,14,21 and 28 post vector injection
Measured: Day 21 post vector injection
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Day 7,14,21 and 28 post vector injection
Measured: Day 28 post vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
1,2,4,6 and 8 weeks after vector injection
Measured: 1 week after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
1,2,4,6 and 8 weeks after vector injection
Measured: 2 weeks after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
1,2,4,6 and 8 weeks after vector injection
Measured: 4 weeks after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
1,2,4,6 and 8 weeks after vector injection
Measured: 6 weeks after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
1,2,4,6 and 8 weeks after vector injection
Measured: 8 weeks after vector injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: No participants met eligibility requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Hall
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor-investigator, Simon Hall, Icahn School of Medicine at Mount Sinai
- Investigators
- Simon Hall, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110526
- Sponsor's protocol ID
- GCO # 01-0595
- Other IDs
- A-11425
- Status last verified
- Oct 2013
- First submitted
- 10 May 2005
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Adenovirus- Mediated IL-12 Gene Transduction in Patients With Radiorecurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00110526
- Acronym / sponsor ID
- GCO # 01-0595
- Conditions
- Prostatic Neoplasms, Neoplasm Recurrence, Local
- Keywords
- Prostate Cancer, Radiation Therapy, Local recurrence, Gene Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants met eligibility requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Simon HallUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Apr 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 May 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 research study is to test a new treatment for prostate cancer. We have been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a virus which produces a cytokine called interleukin-12 (IL-12) into the prostate gland to control tumor growth. We propose to explore the use of adenovirus-mediated human interleukin-12 (Ad.hIL-12) in patients with recurrent non-metastatic prostate cancer following radiation therapy in a Phase I trial. Participants will be placed in rising dose groups with the primary endpoint of learning the maximum dose that can safely be given by injection directly into the prostate gland. Toxicity will be determined through physical examination, laboratory values, and blood levels of cytokines. Evidence of an immune response against prostate proteins will also be monitored. If the treatment works, the cancer will shrink or not grow. This will be monitored by prostate specific antigen (PSA) levels in the blood. However, we do not know if this treatment will be effective. If the PSA continues to rise after treatment, participants will be taken off study and offered other treatment. There is no compensation for participation in this research study. There will be no charge for the treatment with gene therapy or the monitoring associated with this research study. Monitoring will occur in a specially designated clinical research center.
Detailed description
Patients with radiorecurrent prostate cancer have few viable treatment options, both in terms of efficacy and morbidity. Local therapies fail even in highly selected patients due to locally advanced disease, microscopic metastases, and a worsening of the biology of cancer cells. Furthermore, attempts at salvage local treatments have the complications of incontinence, impotence and in some cases unremitting penile pain. Pre-clinical studies in a mouse model of prostate cancer have noted the potential benefit of adenovirus-mediated gene therapy to deliver IL-12 in this clinical scenario. This treatment was able to significantly growth suppress the injected tumor to prolong survival and reduce the number of pre-established metastases. The mechanisms underlying this activity involved both innate immunity (neutrophils and natural killer [NK] cells) and acquired immunity ( T cells) and enhanced expression of Fas to further sensitize Fas/Fas ligand (FasL) killing.
This is a Phase I study. Therefore, the primary objective is finding the Maximum Tolerated Dose. Within this realm will be monitoring of pro-inflammatory cytokines. Secondary aspects will involve correlating important mechanisms identified in the pre-clinical model: induction of T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ad.hIL-12 | Experimental | Genetic: Ad.hIL-12 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A local recurrence of prostate cancer (in or next to gland) following treatment by radiation therapy (either external beam or seed implantation)
- Rising PSA (Prostate Specific Antigen) on at least three occasions separated by two weeks
- Ultrasound guided biopsy to diagnose recurrent disease within the prostate
- No evidence of prostate cancer that has spread on bone scan or Computed Tomography (CT) scan
- No hormone therapy at time of enrollment to the research study
Key exclusion criteria (6 listed)
- Radical prostatectomy for treatment of prostate cancer
- Detectable spread of prostate cancer on bone or CT scan
- Immunosuppressive medication within two months of the study
- Acute infection (any bacterial, viral, fungal infection requiring specific therapy)
- HIV disease
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 |
|---|---|---|
| Ad.hIL-12Ad.hIL-12 intraprostatic injection IND | Genetic | Ad.hIL-12 |
Primary outcome
maximum cytokine gene therapy level
Time frame: after 56 weeks, every 6 months up to 15 years
To study in a Phase I clinical trial the safety of intraprostatic injection of a replication incompetent adenovirus expressing hIL-12 in patients with radiorecurrent prostate cancer
10 secondary outcomes
serum pro-inflammatory cytokines levels
Time frame: up to 15 years
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Time frame: Day 7 post vector injection
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Time frame: Day 14 post vector injection
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Time frame: Day 21 post vector injection
To assess T cell responses pre and post-IL-12 treatment against prostate antigens
Time frame: Day 28 post vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
Time frame: 1 week after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
Time frame: 2 weeks after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
Time frame: 4 weeks after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
Time frame: 6 weeks after vector injection
To assess changes in PSA levels as a surrogate marker for prostate cancer following Ad.hIL-12 gene therapy
Time frame: 8 weeks after vector injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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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.
Simon Hall, MD principal investigator
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad.hIL-12 in people with Prostatic Neoplasms and Neoplasm Recurrence, Local, run by Simon Hall.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
maximum cytokine gene therapy level (time frame: after 56 weeks, every 6 months up to 15 years). 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 24 Oct 2013.