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The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| J591 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-J591 | Drug | 70 mCi/m2 of 177Lu-J591 will be administered on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in tumor perfusion as based on Dynamic Contrast Enhanced (DCE)-MRI study | 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) | Performed after administration of 177LuJ591 between Day 6-9 and on Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in response rate using Response evaluation criteria in solid tumors (RECIST) Criteria | 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). | Objective response will be evaluated from changes in baseline to Day 99 and repeated every 3 months until radiographic progression of disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Tagawa, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
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| Change in the number of subjects who achieve Progression Free Survival | 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. | Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004938 | Esophageal Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004935 | Esophageal Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C478680 | J591 monoclonal antibody |
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