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.

Full Title of Study: “A Pilot Study of 89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2018

Interventions

  • Drug: 89Zr-J591
    • The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.
  • Device: PET/CT Scan
  • Device: MRI
  • Other: Blood draw
    • Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.

Arms, Groups and Cohorts

  • Experimental: 89Zr-J591
    • Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.

Clinical Trial Outcome Measures

Primary Measures

  • Binding of 89Zr-J591
    • Time Frame: 1 year
    • This will be measured by J591 uptake in PET scan.

Participating in This Clinical Trial

Inclusion Criteria

  • Patient age > 25 years old and < 80 years old – Patients with reoccurrence of brain tumor – 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 – Patients with newly diagnosed GBM and one of the following options: – Eligible for surgery after the last research scan. – Significant residual disease after initial surgery – The principal investigator or co-PI must review MRI and CT findings and agree with the presence of significant residual disease – Treatment (non-surgical) naïve – Karnofsky Performance Score ≥ 70 Exclusion Criteria:

  • Laboratory values: – Serum creatinine >2.5 mg/dL. – AST (SGOT) >2.5x ULN. – Bilirubin (total) >1.5x ULN. – Serum calcium >11 mg/dL. – Pregnant or breastfeeding (if a female is of childbearing potential, and unsure of pregnancy status, a standard pregnancy test should be done). – If an initial biopsy demonstrates neoplasm other than GBM – Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject. – Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements – Prior treatment. – 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.

Gender Eligibility: All

Minimum Age: 26 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Collaborator
    • Weill Medical College of Cornell University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph Osborne, MD,PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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