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
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
March 19, 2019
CompletedMarch 19, 2019
August 1, 2018
3.3 years
April 2, 2015
February 22, 2019
February 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Binding of 89Zr-J591
This will be measured by J591 uptake in PET scan.
1 year
Study Arms (1)
89Zr-J591
EXPERIMENTALPatients 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.
Interventions
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.
Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.
Eligibility Criteria
You may qualify if:
- 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):
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
McBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1.
PMID: 38968568DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joseph Osborne, MD, PhD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Osborne, MD,PhD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 7, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
March 19, 2019
Results First Posted
March 19, 2019
Record last verified: 2018-08