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Completed

NCT Number: NCT02410577

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.

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Key information

Age range

26 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

89Zr-J591

Drug

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.

PET/CT Scan

Device

MRI

Device

Blood Draw

Other

Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.

Primary outcomes

  1. Binding of 89Zr-J591

    Time frame: 1 year

    This will be measured by J591 uptake in PET scan.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2015
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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