64Cu-DOTA A2 scFv-Fc2 DM With Positron Emission Tomography for the Imaging of Patients With Locally Advanced or Metastatic PSCA-Expressing Pancreatic Cancer

Description:

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.

Sponsor:

City of Hope Medical Center

Phase:

Phase 1

Contacts:

Jeffrey Y Wong, MD (PRINCIPAL_INVESTIGATOR)

Jeffrey Wong, MD (CONTACT)

jwong@coh.org

626-325-4260

DOTA-A2DM

Isotope(s):
Target(s):
  • PSCA
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DOTA
Inclusion
  • Evidence of locally advanced unresectable or metastatic disease demonstrated by an abnormal imaging scan (computed tomography \[CT\], magnetic resonance imaging \[MRI\], fludeoxyglucose \[FDG\]-PET) within 8 weeks prior to enrollment
  • Advanced (locally or metastatic), histologically confirmed pancreatic adenocarcinoma
  • Karnofsky \> 70%
Exclusion
  • * Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days or five half-lives (whichever is shorter for non-radiation therapy) prior to day 1 of protocol therapy
  • Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial