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 |
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.
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
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...
Click here to add this to my saved trials