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

Primary Purpose

Glioblastoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

89Zr-J591

PET/CT Scan

MRI

Blood draw

About this trial

This is an interventional diagnostic trial for Glioblastoma focused on measuring 89Zr-J591, 15-002

Eligibility Criteria

26 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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):

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.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

89Zr-J591

Arm 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.

Outcomes

Primary Outcome Measures

Binding of 89Zr-J591

This will be measured by J591 uptake in PET scan.

Secondary Outcome Measures

Full Information

NCT ID

NCT02410577

First Posted

April 2, 2015

Last Updated

February 22, 2019

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT02410577

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Weill Medical College of Cornell University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

89Zr-J591, 15-002

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

89Zr-J591

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

89Zr-J591

Intervention Description

The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.

Intervention Type

Device

Intervention Name(s)

PET/CT Scan

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Type

Other

Intervention Name(s)

Blood draw

Intervention Description

Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.

Primary Outcome Measure Information:

Title

Binding of 89Zr-J591

Description

This will be measured by J591 uptake in PET scan.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

26 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Osborne, MD,PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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