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

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ClinicalTrials.gov Identifier: NCT02410577
Recruitment Status : Completed
First Posted : April 7, 2015
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: 89Zr-J591 Device: PET/CT Scan Device: MRI Other: Blood draw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of 89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme
Actual Study Start Date : April 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. Binding of 89Zr-J591 [ Time Frame: 1 year ]
    This will be measured by J591 uptake in PET scan.



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Ages Eligible for Study:   26 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410577


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Joseph Osborne, MD,PhD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02410577     History of Changes
Other Study ID Numbers: 15-002
First Posted: April 7, 2015    Key Record Dates
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019
Last Verified: August 2018
Keywords provided by Memorial Sloan Kettering Cancer Center:
89Zr-J591
15-002
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs