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

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

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Device: MRI; Drug: 89Zr-J591; Device: PET/CT Scan; Other: Blood draw

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: MRI; 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; Other: Blood draw; Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Joseph Osborne, MD,PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: 89Zr-J591; 15-002
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 15-002