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

Completed · Not applicable

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT02410577

Run by

Memorial Sloan Kettering Cancer Center

People needed

2

Starts

2015-04-01

Expected to finish

2018-08-01

Last updated by the study team

2019-03-19

Who can join

Age: 26 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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):
• 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

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.

Where it is running

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

Full record on ClinicalTrials.gov

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