Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
|Prostate Cancer||Drug: 89Zr- DFO-MSTP2109A Drug: 89Zr DFO-MSTP2109A||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer|
- feasibility [ Time Frame: 2 years ]Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.
- safety and tolerability [ Time Frame: 2 years ]All adverse events will be graded for intensity on a scale of 0 to 5. Severity grades will be recorded and based on the CTCAE v4.0.Adverse events will be defined graded using CTCAE V4.0. The safety and tolerability of 89Zr-DFO-MSTP2109A will be assessed using the following primary safety outcome measures: Incidence and nature of incidence, nature, and severity of adverse events; and change in vital signs and clinical laboratory results. Incidence and severity of adverse events will be summarized with descriptive statistics.
- Serial blood draws will be used to estimate the pharmacokinetics (PK) [ Time Frame: 2 years ]Serial blood draws will be used to estimate the pharmacokinetic profile of the 10 and 20mg 89Zr-DFO-MSTP2109A in this patient population.Blood samples will be obtained in green top tube: Just prior to injection of 89Zr-DFO-MSTP2109A (baseline)Approximately 5 ± 2, 15 ± 5, 30 ± 9, 60 ± 19, and 120 to 240 minutes after injection of the tracer. One sample at the time of each subsequent day of imaging (24 + 8h, ~48-96h and ~120-168h post injection).
- biodistribution [ Time Frame: 2 years ]A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution.
- ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer. [ Time Frame: 2 years ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Experimental: 89Zr DFOMSTP2109A tracer Group 1
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
Drug: 89Zr- DFO-MSTP2109A
If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
Experimental: 89Zr-DFO-MSTP2109A tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
Drug: 89Zr DFO-MSTP2109A
If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (~ 3-7 days after injection).
No research blood work will be drawn in Group 2
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774071
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Steven Larson, MD||Memorial Sloan Kettering Cancer Center|