Prostate CancerPhase 1NCT02555397
Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer
A Phase 1 study testing Ad5-yCD/mutTKSR39rep-hIL12 in people with Prostate Cancer, run by Henry Ford Health System at 1 site in United States.
Trial summary
The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy 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?
- Ad5-yCD/mutTKSR39rep-hIL12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 22 Jan 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Biopsy-proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy
- Evidence of biologically active disease as demonstrated by an unequivocally rising serum PSA level that is ≥ 2 ng/mL above the nadir
- PSA < 100 ng/mL
- Age ≥ 18 years
- Karnofsky performance status ≥ 70
- Negative lymph nodes as established by imaging (pelvic CT or pelvic MRI)
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- No evidence of metastatic disease, as evaluated by bone scan and CT scan of the abdomen and pelvis.
- Subjects must have adequate baseline organ function as assessed by the the following laboratory values:
- Adequate renal function with serum creatinine ≤ 1.5 mg/dL
- Platelet count > 100,000/µL
- Absolute neutrophil count > 1,000/µL
- Hemoglobin > 10.0 g/dL
- Bilirubin > 1.5 mg/dL
- AST/SGOT and ALT/SGPT < 3.0 times upper limit of normal (ULN)
- Men of child-producing potential must be willing to consent to use effective contraception for at least 3 months after the gene therapy
- Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study
Who cannot join
- PSA ≥ 100 ng/mL
- Prostate volume > 100 cc
- Pathologically positive lymph nodes or nodes > 1.0 cm on imaging (nodes > 1.0 cm but biopsy negative are allowed.
- Evidence of M1 metastatic disease
- Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment. Subjects must be disease-free for > 5 years
- Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
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- If the subject had prior androgen deprivation therapy (ADT), the subject exhibited biochemical failure while on ADT
- Prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowed; however, subjects must be > 2 years post-completion of chemotherapy at the time of registration. Subjects on Proscar therapy must stop to be eligible)
- Major surgery planned within 3 months of registration
- Severe, active co-morbidity defined as:
- New York Health Association Class II or greater congestive heart failure or active ventricular arrhythmia requiring medication
- Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within last 3 months or precluding study therapy at the time of registration
- Acute infection
- Previous history of liver disease including hepatitis
- Immunosuppressive therapy including systemic corticosteroids (use of inhaled and topical corticosteroids is permitted)
- Impaired immunity or susceptibility to serious viral infections
- Allergy to any product used in the protocol. If the subject has an allergy to Ciproflaxin, another antibiotic can be substituted at the discretion of the treating physician
- Serious medical or psychiatric illness or concomitant medication, which, in the judgement of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy
- Conditions
- Prostate Cancer
- Being tested
- Ad5-yCD/mutTKSR39rep-hIL12
- Keywords
- Prostate Cancer, Locally Recurrent, Gene Therapy, IL-12, Adenovirus
- Medical subject headings
- Prostatic Neoplasms, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad5-yCD/mutTKSR39rep-hIL12Biological
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles. Receives: Biological: Ad5-yCD/mutTKSR39rep-hIL12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-dependent Toxicity
Measured: 30 days from date of adenovirus injection (defined as day 1)
Secondary outcomes (5)
PSA Response
Measured: 2 years
Freedom From Biochemical/Clinical Failure (FFF)
Measured: 2 years
PSA Doubling Time (PSADT)
Measured: 2 years
Disease-specific and Overall Survival
Measured: 5 years
Quality of Life (QOL)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion16 Jun 2019
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farzan Siddiqui, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555397
- Sponsor's protocol ID
- Prostate Cancer (9829)
- Status last verified
- Jul 2024
- First submitted
- 17 Sep 2015
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Freytag SO, Barton KN, Zhang Y. Efficacy of oncolytic adenovirus expressing suicide genes and interleukin-12 in preclinical model of prostate cancer. Gene Ther. 2013 Dec;20(12):1131-9. doi: 10.1038/gt.2013.40. Epub 2013 Jul 11.
PubMed 23842593Nyati S, Stricker H, Barton KN, Li P, Elshaikh M, Ali H, Brown SL, Hwang C, Peabody J, Freytag SO, Movsas B, Siddiqui F. A phase I clinical trial of oncolytic adenovirus mediated suicide and interleukin-12 gene therapy in patients with recurrent localized prostate adenocarcinoma. PLoS One. 2023 Sep 15;18(9):e0291315. doi: 10.1371/journal.pone.0291315. eCollection 2023.
PubMed 37713401
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
- ClinicalTrials.gov ID
- NCT02555397
- Acronym / sponsor ID
- Prostate Cancer (9829)
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Locally Recurrent, Gene Therapy, IL-12, Adenovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this phase 1 study is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy in men with locally recurrent prostate cancer after definitive radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Biological: Ad5-yCD/mutTKSR39rep-hIL12Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Biopsy-proven local recurrence of prostate cancer at least one year after the completion of definitive radiation therapy
- Evidence of biologically active disease as demonstrated by an unequivocally rising serum PSA level that is ≥ 2 ng/mL above the nadir
- PSA < 100 ng/mL
- Age ≥ 18 years
- Karnofsky performance status ≥ 70
Key exclusion criteria (18 listed)
- PSA ≥ 100 ng/mL
- Prostate volume > 100 cc
- Pathologically positive lymph nodes or nodes > 1.0 cm on imaging (nodes > 1.0 cm but biopsy negative are allowed.
- Evidence of M1 metastatic disease
- Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment. Subjects must be disease-free for > 5 years
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 |
|---|---|---|
| Ad5-yCD/mutTKSR39rep-hIL12Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1 | Biological | Single |
Primary outcome
Dose-dependent Toxicity
Time frame: 30 days from date of adenovirus injection (defined as day 1)
5 secondary outcomes
PSA Response
Time frame: 2 years
Freedom From Biochemical/Clinical Failure (FFF)
Time frame: 2 years
PSA Doubling Time (PSADT)
Time frame: 2 years
Disease-specific and Overall Survival
Time frame: 5 years
Quality of Life (QOL)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23842593Freytag SO, Barton KN, Zhang Y. Efficacy of oncolytic adenovirus expressing suicide genes and interleukin-12 in preclinical model of prostate cancer. Gene Ther. 2013 Dec;20(12):1131-9. doi: 10.1038/gt.2013.40. Epub 2013 Jul 11.
- Derived from this study: PubMed 37713401Nyati S, Stricker H, Barton KN, Li P, Elshaikh M, Ali H, Brown SL, Hwang C, Peabody J, Freytag SO, Movsas B, Siddiqui F. A phase I clinical trial of oncolytic adenovirus mediated suicide and interleukin-12 gene therapy in patients with recurrent localized prostate adenocarcinoma. PLoS One. 2023 Sep 15;18(9):e0291315. doi: 10.1371/journal.pone.0291315. eCollection 2023.
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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 Ad5-yCD/mutTKSR39rep-hIL12 in people with Prostate Cancer, run by Henry Ford Health System 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 16 inclusion and 18 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 10 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-dependent Toxicity (time frame: 30 days from date of adenovirus injection (defined as day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555397, 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 10 Oct 2024.