Monitor Adverse EventsPhase 1/2NCT01929239
Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
A Phase 1/2 study testing Anti-PSMA Designer T Cells in people with Monitor Adverse Events, run by Roger Williams Medical Center at 1 site in United States.
Trial summary
This is a Phase Ib Pilot study of anti-PSMA designer T cells in metastatic prostate cancer. Subjects will receive escalating doses of T cells, with either low or moderate dose Interleukin 2. The T cells are collected by pheresis and then genetically modified, and given in a one time infusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Monitor Adverse Events
- What is being tested?
- Anti-PSMA Designer T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2018
- Phase
- Phase 1/2
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5.2.1 Patient with histologically confirmed diagnosis of prostate cancer.
- 5.2.2 Patient with rising serum PSA,(prostate specific antigen).
- 5.2.3 Tumor is hormone refractory, as documented by rising PSA with two values separated in time. Patients may enroll if they have a rising PSA after withdrawal of androgen therapy but if enrolled onto this protocol on androgen ablation therapy, they must remain on the androgen therapy for the duration of this protocol. Patients may enroll if tumor is not hormone refractory only if they refuse hormone therapy at this time, and that they understand that hormone therapy is standard treatment for their disease at this stage.
- 5.2.4 Patient must be at least 18 years of age.
- 5.2.5 Patient able to understand and sign informed consent.
- 5.2.6 Patient with a life expectancy of greater than four months.
Show all 16Show fewer
- 5.2.7 Patient with performance status of 0 to 1. (http://www.ecog.org/general/perfstat.html).
- 5.2.8 Patient with adequate organ function as defined by:
- 5.2.8.1 ANC 1.0, platelets 50,000, Hgb 8.0; patient may be transfused to achieve Hgb 8.0 to satisfy enrollment criteria, or as otherwise indicated by symptoms for Hgb >8.0.
- 5.2.8.2 Creatinine 1.5mg/dl or creatinine clearance 60cc/min.
- 5.2.8.3 Direct bilirubin 1.5 mg/dl.
- 5.2.8.4 No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, including atrial fibrillation/atrial flutter, evidence of prior myocardial infarction by history or EKG. A normal cardiac stress test for inducible ischemia or arrhythmia within 12 weeks prior to enrollment for all patients over 50 years old or those with abnormal EKG or any history or symptoms suggestive of cardiac disease.
- 5.2.8.5 No serious, symptomatic obstructive or emphysema¬tous lung disease, or asthma requiring intravenous medications within the past 12 months; no serious lung disease associated with dyspnea at normal activity levels (grade III) or at rest (grade IV), due to any cause (including cancer metastases and pleural effusions). The patient will be ineligible if PFTs show an FEV1 <1.3 liters or a DLCO <50% within 12 weeks of study entry.
- For patients enrolling in cohorts IIA, IIB, and III:
- 5.2.9 Patients with disease in the bone or other site(s) have biopsy-able tumor (at radiologically- or externally-accessible site), and willing to undergo biopsy as specified in 6.3.6. For these groups, patients with >5 lesions bone scan positive lesions will be preferred to increase the yield of blind bone marrow biopsies.
- Alternatively, patients with bone or extra-skeletal lesions may be biopsied by CT guided or open procedure.
Who cannot join
- 5.3.1 Patients with serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic, or allergic disease based on history, physical exam and laboratory tests will be excluded, as outlined in section 5.2.9.
- 5.3.2 Patients with active clinical disease caused by CMV, hepatitis B or C, HIV or tuberculosis will be excluded from the study.
- 5.3.3 Patients who have had cytotoxic and/or radiation therapy in the four weeks prior to entry or who have initiated anti-androgen therapy less than six weeks prior to entry will be excluded.
- 5.3.4 Patients with other concurrent malignancies will be excluded.
- 5.3.5 Patients requiring systemic steroids will be excluded.
- 5.3.6 Patients with prior investigational therapies within the 4 weeks prior to entry will be excluded.
- 5.3.7 Patients previously exposed to mouse antibody will be excluded, unless proven by ELISA to have a negative baseline human anti-mouse antibody (HAMA) titer.
- 5.3.8 Patients who have had irradiation to whole pelvis or to more than 25% of total marrow will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roger Williams Medical Center
Providence, Rhode Island, 02908
About this study
Official title: Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Prostate Cancer After Non-Myeloablative Conditioning
This is a Phase Ib Pilot study of anti-PSMA designer T cells in metastatic prostate cancer. Subjects will receive escalating doses of T cells, with either low or moderate dose Interleukin 2. The T cells are collected by pheresis and then genetically modified, and given in a one time infusion.
- Conditions
- Monitor Adverse Events
- Being tested
- Anti-PSMA Designer T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PSMA Designer T CellsDrug
| Study group | Role | What they receive |
|---|---|---|
| Anti PSMA Designer T Cells | Experimental | Open Label, subjects receive anti PSMA designer T cells, plus IL2, low or moderate dose. Receives: Drug: Anti-PSMA Designer T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startMar 2006
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitor Adverse EventsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roger Williams Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard P Junghans, PhD, MD, Principal investigator, Roger Williams Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929239
- Sponsor's protocol ID
- W81XWH-05-1-0408
- Status last verified
- Jun 2016
- First submitted
- 22 Aug 2013
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Prostate Cancer After Non-Myeloablative Conditioning
- ClinicalTrials.gov ID
- NCT01929239
- Acronym / sponsor ID
- W81XWH-05-1-0408
- Conditions
- Monitor Adverse Events
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Roger Williams Medical CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Aug 2013 (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 is a Phase Ib Pilot study of anti-PSMA designer T cells in metastatic prostate cancer. Subjects will receive escalating doses of T cells, with either low or moderate dose Interleukin 2. The T cells are collected by pheresis and then genetically modified, and given in a one time infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti PSMA Designer T Cells | Experimental | Drug: Anti-PSMA Designer T CellsOpen Label, subjects receive anti PSMA designer T cells, plus IL2, low or moderate dose. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 5.2.1 Patient with histologically confirmed diagnosis of prostate cancer.
- 5.2.2 Patient with rising serum PSA,(prostate specific antigen).
- 5.2.3 Tumor is hormone refractory, as documented by rising PSA with two values separated in time. Patients may enroll if they have a rising PSA after withdrawal of androgen therapy but if enrolled onto this protocol on androgen ablation therapy, they must remain on the androgen therapy for the duration of this protocol. Patients may enroll if tumor is not hormone refractory only if they refuse hormone therapy at this time, and that they understand that hormone therapy is standard treatment for their disease at this stage.
- 5.2.4 Patient must be at least 18 years of age.
- 5.2.5 Patient able to understand and sign informed consent.
Key exclusion criteria (8 listed)
- 5.3.1 Patients with serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic, or allergic disease based on history, physical exam and laboratory tests will be excluded, as outlined in section 5.2.9.
- 5.3.2 Patients with active clinical disease caused by CMV, hepatitis B or C, HIV or tuberculosis will be excluded from the study.
- 5.3.3 Patients who have had cytotoxic and/or radiation therapy in the four weeks prior to entry or who have initiated anti-androgen therapy less than six weeks prior to entry will be excluded.
- 5.3.4 Patients with other concurrent malignancies will be excluded.
- 5.3.5 Patients requiring systemic steroids will be excluded.
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 |
|---|---|---|
| Anti-PSMA Designer T Cells | Drug | Anti PSMA Designer T Cells |
Primary outcome
Number of participants with adverse events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Richard P Junghans, PhD, MD principal investigator
Roger Williams Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-PSMA Designer T Cells in people with Monitor Adverse Events, run by Roger Williams Medical Center 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 8 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: paused, as of the sponsor's last update on 17 Jun 2016. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of participants with adverse events (time frame: 30 days). 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 17 Jun 2016.