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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

89Zr-J591

Intervention Type DRUG

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.

PET/CT Scan

Intervention Type DEVICE

MRI

Intervention Type DEVICE

Blood draw

Intervention Type OTHER

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

Interventions

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89Zr-J591

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 DRUG

PET/CT Scan

Intervention Type DEVICE

MRI

Intervention Type DEVICE

Blood draw

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

26 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No