Glioblastoma
Conditions
Keywords
89Zr-J591, 15-002
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.
Interventions
DRUG89Zr-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.
DEVICEPET/CT Scan
DEVICEMRI
OTHERBlood draw
Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.
Sponsors
Weill Medical College of Cornell University
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binding of 89Zr-J591 | 1 year | This will be measured by J591 uptake in PET scan. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: 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
MRI
Blood draw: Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | 89Zr-J591 |
|---|---|
| Age, Continuous | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Binding of 89Zr-J591
This will be measured by J591 uptake in PET scan.
Time frame: 1 year
Population: Data were not collected.