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

Phase 1

Completed

• Conditions: Prostate Cancer; Pancreatic Cancer; Bladder Cancer
• Interventions: Radiation: [124I] PSCA-Minibody PET/CT imaging of the whole body

• Registration Number: NCT02092948
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.). 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.

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.

Study Timeline

• Study Start: 2013-08-22
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Status Verified: 2016-05
• Primary Completion: 2017-01-06
• Study Completion: 2017-01-06
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	[124I] PSCA-Minibody PET/CT imaging of the whole body	Patients 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.

Primary Outcome Measures

Name	Time	Method
Assess the safety of [124I] PSCA-Minibody	up to 3 months	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

Secondary Outcome Measures

Name	Time	Method
Assess the ability of [124I] PSCA-Minibody to image known metastatic disease	1 Day of scan	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.
Compare the sensitivity and specificity of [124I] PSCA-Minibody with conventional imaging	1 Day of scan	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.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States