Trials / Completed
CompletedNCT00967577
177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.
Detailed description
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.
Conditions
- Kidney Cancer
- Head and Neck Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Pancreatic Cancer
- Ovarian Cancer
- Esophageal Cancer
- Gliomas
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 177Lu-J591 | 70 mCi/m2 of 177Lu-J591 will be administered on Day 1. |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2018-06-01
- Completion
- 2021-12-31
- First posted
- 2009-08-28
- Last updated
- 2022-02-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00967577. Inclusion in this directory is not an endorsement.