This clinical trial tests the safety, side effects, best dose and feasibility of using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography for the imaging of patients with PSCA-expressing pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 64Cu-DOTA A2 scFv-Fc2 DM. Because PSCA expressing pancreatic cancers take up 64Cu-DOTA A2 scFv-Fc2 DM it can be seen with PET. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. Using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography may be a safe and feasible way to obtain diagnostic images of patients with locally advanced or metastatic PSCA-expressing pancreatic cancer.
PRIMARY OBJECTIVE: I. To evaluate the safety and feasibility of prostate stem cell antigen (PSCA) imaging using 64Cu-DOTA-A2DM in patients with locally advanced or metastatic pancreatic cancer. SECONDARY OBJECTIVES: I. To evaluate images of 64Cu-DOTA-A2DM. II. To determine pharmacokinetics of 64Cu-DOTA-A2DM. III. To determine the optimal unlabeled dose of DOTA-A2DM for radioimmunotherapy trials (RIT). IV. To conduct radiation dose estimation for RIT trials OUTLINE: This is a dose escalation study of 64Cu-DOTA A2 scFv-Fc2 DM. Patients receive unlabeled DOTA-A2DM intravenously (IV) then 2-3 hours later patients receive labeled 64Cu-DOTA-A2DM, over 3-5 minutes on day 0. Patients undergo PET scan on day 1 and 2. Patients undergo urine sample collection during screening and blood sample collection throughout the study. After completion of study intervention, patients are followed up at 30 and 90 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
Undergo blood sample collection
Given 64Cu-DOTA-A2DM IV
Undergo PET scan
DOTA-A2DM IV
City of Hope Medical Center
Duarte, California, United States
Incidence of adverse events
Graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 6.0.
Time frame: Up to 90 days
Dose limiting toxicity
Defined as any of the following that occur during the first 2 days post the administration of radiolabeled A2DM that are attributed as possibly, probably, or definitely related to protocol therapy.
Time frame: Up to day 2
Radiolabel uptake in prominent lesions and adjacent non-tumor tissue and select organs
Measured as maximum single-voxel standardized uptake value (SUVmax) and mean standardized uptake value.
Time frame: At day 1 and 2
64Cu activity concentration
Time frame: At 0-1, 4-6, 21-25, and 46-50 hours after injection
Ratios of tumor to non-tumor activity concentrations
Measured in the select organs (SUVmean) at different protein doses and time points will be used to determine optimal protein dose.
Time frame: Up to 90 days
Imaging-based dosimetry
Quantified in the liver, spleen, heart, and the lumbar vertebrae as calculated by organ level internal dose assessment-based standard phantom data.
Time frame: On day 1 and 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.