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

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Weill Medical College of Cornell University
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

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.