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



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:26 - 79
Updated:3/21/2019
Start Date:April 2015
End Date:August 2018

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

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.


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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Joseph Osborne, MD, PhD
Phone: 212-639-7788
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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from
New York, NY
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