Clinical trial · Interventional
89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme
A Pilot Study of 89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme
NCT02410577CI-TRIAL-00037690completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-J591 | Drug | — | UNRESOLVED |
| Blood draw | Other | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
| PET/CT Scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 89Zr-J591
- description
- Patients will not be required to fast prior to imaging with 89Zr-J591 injection or imaging. The total dose of humanized mAb J591 will be 20mg. Patients will first receive an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody (IND11407) followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg). Administration of the cold antibody will be followed by the labeled compound.
- interventionNames
- Drug: 89Zr-J591
- Device: PET/CT Scan
- Device: MRI
- Other: Blood draw
Primary outcomes (1)
- measure
- Binding of 89Zr-J591
- timeFrame
- 1 year
- description
- This will be measured by J591 uptake in PET scan.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 26 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMcBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1. PMID 38968568