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Prostate CancerPhase 1NCT02092948

Phase I Study to evaluate124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer

A Phase 1 study testing [124I] PSCA-Minibody PET/CT imaging of the whole body in people with Prostate Cancer and Pancreatic Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to determine whether positron emission tomography (PET), using the new imaging drug [124 I] PSCA-Minibody can be used for imaging prostate, pancreatic or bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs, etc.). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer, Pancreatic Cancer, Bladder Cancer
What is being tested?
[124I] PSCA-Minibody PET/CT imaging of the whole body
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
22 Aug 2013to 6 Jan 2017
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria (subjects must meet all of the following criteria in order to be enrolled in this study):

  1. Histological diagnosis of prostate, bladder or pancreatic cancer.
  2. Evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI, or FDG-PET within 6 weeks (with no new interval treatment before imaging trial)
  3. Expected survival ≤ 6 months
  4. Provide written informed consent and willing to comply with protocol requirement
  5. ≥ 18 years of age
  6. The following laboratory results should be within the following limits within 4 weeks prior to study day 1:
  7. PSA > 5 (only for prostate cancer patients)
  8. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l
  9. Platelet count ≥ 100 x 10^9/l
  10. Serum bilirubin ≤ 2.0 mg/dl
  11. Aspartate amino transaminase (AST) ≤ 2.5 x ULN
  12. Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  13. Serum creatinine ≤ 2.0 mg/dl (calculated creatinine clearance > 45 ml/min)
  14. Able to undergo imaging studies, as well as conventional bone and body imaging, as well as 124I-A11 PSCA minibody experimental scan.

Exclusion Criteria (subjects meeting any of the following criteria will not be enrolled in this study):

  1. Inadequate venous access (two antecubital or equivalent venous access sites)
  2. Administration of a radionuclide within 5 physical half-lives prior to projected administration of 124I-A11 PSCA minibody
  3. New York Heart Association Class III/IV cardiac disease.
  4. History of autoimmune hepatitis
  5. Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study
  6. Subjects weighing ≥ 350 lbs or are unable to fit in the imaging gantry
  7. Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.
  8. Iodine Allergy, hyperthyroidism, or Grave's disease.
  9. Any other disease or medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, Los Angeles

    Los Angeles, California, 90024

Other trials in United States

About this study

Official title: A Phase I Open Label Study to Evaluate the Tumor-targeting Properties and Safety of 124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer.

The purpose of the study is to determine whether positron emission tomography (PET), using the new imaging drug [124 I] PSCA-Minibody can be used for imaging prostate, pancreatic or bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs, etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder cancers.

Read the detailed description

The people doing this study want to find out:

  1. Can the [124 I] PSCA-Minibody be used to image prostate, pancreatic and bladder cancer?
  2. How much of the PSCA Minibody needs to be used to see the prostate, pancreatic or bladder cancer?
  3. Does the PSCA Minibody see more/same/fewer lesions than are identified on traditional scans such as bone scan or CT scan?

To answer these questions, we want to evaluate how [124 I] PSCA-Minibody is distributed throughout the body in 20 patients with prostate, pancreatic or bladder cancer. This is done with PET/CT imaging. A PET/CT scan is a non-invasive x-ray test that uses a special camera to take pictures of the inside of your body. It can "see" the radiation given off by tiny particles called positrons in the radioactive drug injected into you while also taking pictures of the organs within the body. For this study the radioactive substance is [124 I] PSCA-Minibody.

The scanning for this study is done with an imaging procedure in the department of Nuclear Medicine during which the experimental drug [124 I] PSCA-Minibody will be administered by intravenous (i.v.) infusion. An experimental drug is one that is not yet approved by the US Food and Drug Administration (FDA). [124 I] PSCA-Minibody is a combination of a monoclonal antibody, and I-124, a radioactive type of iodine. The iodine will make the antibody and the cancer cells visible in a PET scan. PET stands for positron emission tomography and uses radioactivity to image the inside of the body. A CT scan uses x-rays to look at the internal organs in the body. This study will use a combination PET/CT to look at the cancer cells in your body that have taken up the study agent as well as to see their location in your body.

Being tested
[124I] PSCA-Minibody PET/CT imaging of the whole body
Keywords
metastatic, PSCA, minibody, PET/CT
Medical subject headings
Prostatic Neoplasms, Pancreatic Neoplasms, Urinary Bladder Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [124I] PSCA-Minibody PET/CT imaging of the whole bodyRadiation

    Whole body Imaging

Study groups in NCT02092948
Study groupRoleWhat they receive
All patientsExperimentalPatients will receive one intravenous dose of 4 mg, 20mg or 40 mg of A11 minibody labeled with 5 mCi (185 MBq) of 124I, followed by [124I] PSCA-Minibody PET/CT imaging of the whole body.
Receives: Radiation: [124I] PSCA-Minibody PET/CT imaging of the whole body

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the safety of [124I] PSCA-Minibody

    Safety measures: adverse events including laboratory adverse events will be graded and summarized according to the National Cancer Institute CTCAE, version 4.03.

    • Laboratory tests (CBC with differential, platelets, serum electrolytes, BUN, creatinine, chemistry, urine analysis)
    • Vital signs (upright and supine blood pressure, heart rate, respiratory rate, oral temperature, and weight)
    • Physical examination
    • HAMBA tier in serum

    Measured: up to 3 months

Secondary outcomes (2)

  1. Assess the ability of [124I] PSCA-Minibody to image known metastatic disease

    Binary qualitative reading of [124I] PSCA-Minibody based PET imaging in subjects with known metastatic prostate, pancreatic, or bladder cancer to decide on the presence or absence of targeting to this cancer.

    Measured: 1 Day of scan

  2. Compare the sensitivity and specificity of [124I] PSCA-Minibody with conventional imaging

    Number, localization and size of metastatic lesions by 124I-A11 based PET/CT imaging and comparison to standard of care imaging with CT and bone scan.

    Measured: 1 Day of scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2014 (estimated)
  2. Study start22 Aug 2013
  3. Primary completion6 Jan 2017
  4. Study completion6 Jan 2017

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02092948
Sponsor's protocol ID
13-000922
Other IDs
MNBD-PROT01
Status last verified
May 2016
First submitted
18 Mar 2014
Last updated
27 Jul 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [124I] PSCA-Minibody PET/CT imaging of the whole body in people with Prostate Cancer and Pancreatic Cancer, run by Jonsson Comprehensive Cancer 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?

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 27 Jul 2020. 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.

What does the primary outcome measure?

Assess the safety of [124I] PSCA-Minibody (time frame: up to 3 months). 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 NCT02092948.

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 27 Jul 2020.

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