Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

This study is currently recruiting participants.
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01774071
First received: January 11, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to see if a new diagnostic research agent named 89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long 89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by a PET scanner. The results of this study may help researchers know whether 89Zr-DFO-MSTP2109A can be used as a diagnostic agent for finding prostate cancer that have STEAP1 on its surface with a PET scanner. The reason why identifying STEAP1 on prostate cancer cells is that new therapies are being developed to target STEAP1 prostate cancer cells.


Condition Intervention Phase
Prostate Cancer
Drug: 89Zr- DFO-MSTP2109A
Drug: 89Zr DFO-MSTP2109A
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution.


Secondary Outcome Measures:
  • ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  • 1-4 hours after the injection
  • 24 hours after the injection (the next day, Day 2)
  • 48-120 hours after the injection (on either Day 3, 4, or 5)
  • 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
  • Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
  • At each time of your scheduled PET scan.
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


  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be included in this study, patients should be eligible for enrollment into protocol 11-016 (therapy with the DSTP3086S ADC) or meet all of the following criteria:
  • Patients meeting the criteria for enrollment on research protocol 11-016 to receive DSTP3086S ADC (therapeutic ADC based on MSTP2109A) will be the preferred patients for this study. Patients that are to receive DSTP3086S will not be injected with DSTP2086S until imaging with 89Zr-DFOMSTP2109A is finished, approximately 1 week.
  • Adult male > 21years of age
  • Visible lesions by either CT, bone scan or MRI consistent with metastatic disease
  • Metastatic progressive disease
  • Imaging modalities:
  • Bone scan: new osseous lesion and/or MRI or CT: An increase in measurable soft tissue disease or the appearance of new sites of disease.

Or

  • PSA changes over range of value 26%
  • Patients with histologically confirmed prostate cancer at MSKCC
  • STEAP1 antigen positive tissue known from prior IHC testing or if STEAP1 status is not known archival sample will be sent to Genentech for IHC. Samples need to be positive, when feasible metastatic lesions will be tested preferentially rather than the primary.
  • Performance status of 60 or higher (Karnofsky scale) (Appendix A)
  • Ability to understand and willingness to sign a written informed consent document
  • PSA levels to be taken within 2 weeks of antibody administration.

Exclusion Criteria:

  • Patients meeting any of the following exclusion criteria will not be eligible for study entry:
  • Previous anaphylactic reaction to human, humanized or chimeric antibody
  • Hematologic
  • Platelets <75K/mcL
  • ANC <1.0 K/mcL
  • Hepatic laboratory values
  • AST/ALT >2.5 x ULN
  • Renal laboratory values
  • Bilirubin >1.5 x ULN (institutional upper limits of normal)
  • eGFR < 30mL/min/1.73m2
  • Patients with history of hypersensitivity reaction to any component of 89Zr-DFOMSTP2109A, including DFO
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774071

Contacts
Contact: Jorge Carrasquillo, MD 212-639-2459
Contact: Michael Morris, MD 646-422-4469

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jorge Carrasquillo, MD    212-639-2459      
Contact: Michael Morris, MD    646-422-4469      
Principal Investigator: Jorge Carrasquillo, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Genentech
Investigators
Principal Investigator: Jorge Carrasquillo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01774071     History of Changes
Other Study ID Numbers: 12-178
Study First Received: January 11, 2013
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
89Zr-DFO-MSTP2109A
tracer
pet scan
12-178

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014