Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | January 2017 |
| Contact: | Neeta Pandit-Taskar, MD |
| Email: | pandit-n@mskcc.org |
| Phone: | 212-639-7372 |
A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an
immunoPET tracer for metastatic prostate cancer. Individuals participating in this study
will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the
injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The
purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect
prostate cancer, and optimal time point and dose level for imaging.
immunoPET tracer for metastatic prostate cancer. Individuals participating in this study
will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the
injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The
purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect
prostate cancer, and optimal time point and dose level for imaging.
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited
(Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been
previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and
bone lesions in advanced metastatic prostate cancer.
(Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been
previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and
bone lesions in advanced metastatic prostate cancer.
Inclusion Criteria:
- Adult male >/= 18 years of age
- Patients with histologically confirmed prostate cancer
- Progressive disease manifest (within 6 weeks of screening) by either
- imaging modalities (bone scan, MRI or CT) OR
- biochemical progression (PSA)
- Performance status of 60 or higher on Karnofsky scale
- Subject's schedule permits compliance with all study procedures
- Ability to understand and willingness to sign a written informed consent form
Exclusion Criteria:
- Previous anaphylactic reaction to huJ591 antibody or FDG imaging
- On any new anticancer therapy (GnRH analog allowed) while on the study
- Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5
ULN if Alkaline Phostphatase >2.5 ULN
- Renal lab values: Creatinine > 1.5 ULN
- Other severe acute or chronic medical condition that may increase the risk associated
with study participation or investigational product administration
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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