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

Not Applicable

Completed

• Conditions: Glioblastoma
• Interventions: Drug: 89Zr-J591; Device: PET/CT Scan; Device: MRI; Other: Blood draw

• Registration Number: NCT02410577
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-07
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2019-02-22
• Results First Submitted QC: 2019-02-22
• Last Update Submitted: 2019-02-22
• Results First Posted: 2019-03-19
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
89Zr-J591	89Zr-J591	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.
89Zr-J591	PET/CT Scan	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.
89Zr-J591	MRI	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.
89Zr-J591	Blood draw	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.

Primary Outcome Measures

Name	Time	Method
Binding of 89Zr-J591	1 year	This will be measured by J591 uptake in PET scan.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States