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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410577
• Other study ID #: 15-002
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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

• MRI

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binding of 89Zr-J591	This will be measured by J591 uptake in PET scan.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center