Clinical Trial · NCT02092948

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

Overview

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.

Sponsor

Jonsson Comprehensive Cancer Center (UCLA)

Phase

Phase 1

Contacts

Alan Pantuck, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02092948

Eligibility

Inclusion

  • Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.
  • Serum bilirubin ≤ 2.0 mg/dl
  • PSA \> 5 (only for prostate cancer patients)
  • 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):
  • New York Heart Association Class III/IV cardiac disease.
  • Administration of a radionuclide within 5 physical half-lives prior to projected administration of 124I-A11 PSCA minibody
  • Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study
  • Inclusion Criteria (subjects must meet all of the following criteria in order to be enrolled in this study):
  • Expected survival ≤ 6 months
  • 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)
  • Iodine Allergy, hyperthyroidism, or Grave's disease.
  • The following laboratory results should be within the following limits within 4 weeks prior to study day 1:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/l
  • Aspartate amino transaminase (AST) ≤ 2.5 x ULN
  • Subjects weighing ≥ 350 lbs or are unable to fit in the imaging gantry
  • Serum creatinine ≤ 2.0 mg/dl (calculated creatinine clearance \> 45 ml/min)
  • Inadequate venous access (two antecubital or equivalent venous access sites)
  • Histological diagnosis of prostate, bladder or pancreatic cancer.
  • Platelet count ≥ 100 x 10\^9/l
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • 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.
  • History of autoimmune hepatitis

Exclusion

Exclusion criteria not yet provided.

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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