177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00967577|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2009
Last Update Posted : February 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Head and Neck Cancer Breast Cancer Non-small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Ovarian Cancer Esophageal Cancer Gliomas||Drug: 177Lu-J591||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study|
|Actual Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2021|
70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
Other Name: monoclonal antibody J591
- Change in tumor perfusion as based on Dynamic Contrast Enhanced (DCE)-MRI study [ Time Frame: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29. ]
- Change in tumor perfusion based on changes in cellularity as assessed using Diffusion-weighted imaging (DWI) [ Time Frame: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29. ]
- Changes in response rate using Response evaluation criteria in solid tumors (RECIST) Criteria [ Time Frame: Objective response will be evaluated from changes in baseline to Day 99 and repeated every 3 months until radiographic progression of disease. ]Through RECIST criteria, objective response will be evaluated by taking into account the measurement of the longest diameter only for all target lesions on CT scans as well as normalization of serum tumor markers (if applicable).
- Change in the number of subjects who achieve Progression Free Survival [ Time Frame: Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease ]Progression free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. This will be calculated from the time of treatment (day of 177Lu-J591 infusion) until radiographic progression or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967577
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Scott Tagawa, MD||Weill Cornell Medicine|