177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.
Head and Neck Cancer
Non-small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study|
- Change in tumor perfusion as based on DCE-MRI study as well as changes in cellularity as assessed using DWI. [ Time Frame: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29. ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
Other Name: monoclonal antibody J591
177Lu-J591 is made up of two compounds called J591 and 177Lutetium (177Lu) that are joined together by a connecting molecule called "DOTA". J591 is a monoclonal antibody, or a type of protein. 177Lu is a radioactive molecule that is being tested for the possible treatment of cancer when joined to monoclonal antibodies. J591 attaches to a protein called prostate specific membrane antigen (PSMA) found in the body. PSMA is mostly found in normal and cancerous prostate cells. In addition, however, PSMA has also been found on the vasculature (blood vessels) that supply multiple types of cancer including colorectal, kidney, bladder, head and neck, breast, non-small cell lung, pancreas, ovary, esophagus and gliomas.
We hope that 177Lu-J591 will seek out blood vessels that supply these tumors and deliver a dose of radiation (from the 177Lu molecule) to the areas of cancer, without affecting target blood vessel that are not associated with the cancer.
Zirconium-89 (89Zr) is a radioactive tracer that allows special scans to be performed prior to administration of the study drug to determine where the antibody goes in the body and to screen the tumor's blood vessels to see if they attract J591. Again, DOTA is used to join the radioactive material to J591. 89Zr-J591 is not being given to treat cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967577
|Contact: Lauren Emmerich, R.N.||firstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Lauren Emmerich, R.N. 212-746-1851 email@example.com|
|Principal Investigator: Scott Tagawa, M.D.|
|Sub-Investigator: David Nanus, M.D.|
|Sub-Investigator: Linda Vahdat, M.D.|
|Sub-Investigator: Tessa Cigler, M.D.|
|Sub-Investigator: Tsiporah Shore, M.D.|
|Sub-Investigator: Allyson Ocean, M.D.|
|Sub-Investigator: Himisha Beltran, M.D.|
|Sub-Investigator: Tang Dai, M.D.|
|Sub-Investigator: Ana Molina, M.D.|
|Sub-Investigator: Ronard Scheff, M.D.|
|Sub-Investigator: Manish Shah, M.D.|