Clinical Trial · NCT02410577

89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme

Overview

The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for humanized antibody called J591, that is attached to a radioactive material called Zirconium-89) in patients with glioblastoma multiforme.

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

N/A

Contacts

Joseph Osborne, MD,PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02410577

Eligibility

Inclusion

  • Eligible for surgery after the last research scan.
  • Karnofsky Performance Score ≥ 70
  • Significant residual disease after initial surgery
  • Treatment (non-surgical) naïve
  • Patients with newly diagnosed GBM and one of the following options:
  • The principal investigator or co-PI must review MRI and CT findings based on the radiologic assessment provided they meet the following imaging criteria (as established in the clinical trial 09-177):OR
  • The principal investigator or co-PI must review MRI and CT findings and agree with the presence of significant residual disease

Exclusion

  • Pregnant or breastfeeding (if a female is of childbearing potential, and unsure of pregnancy status, a standard pregnancy test should be done).
  • Prior treatment.
  • Bilirubin (total) \>1.5x ULN.
  • Other serious illness (es), which might preclude completion of this, study or interfere with determination of causality of any adverse effects experienced in this study.
  • Laboratory values:
  • AST (SGOT) \>2.5x ULN.
  • Serum calcium \>11 mg/dL.
  • If an initial biopsy demonstrates neoplasm other than GBM
  • Serum creatinine \>2.5 mg/dL.
  • Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject.