Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Histologically, or cytologically documented, advanced stage, malignant adult solid tumors (except prostate cancer) that are refractory to, or recurrent from, standard therapy or for which no curative standard therapy exists.
- - Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan, CXR and/or bone scan - Progressive disease manifest by: Development of new lesions or an increase in size of preexisting lesions on imaging study or by physical examination.
- - Subjects must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drug for at least 4 weeks prior to J591 administration in this trial - All subjects must have archived or current tissue (from a primary or metastatic focus) available for PSMA determination.
- - Subjects on bisphosphonate therapy or denosumab must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
- - Subjects will be informed as to the potential risk of procreation while participating on this trial and will be advised to use effective contraception during the entire study period.
- - Use of red blood cell or platelet transfusions within 4 weeks of treatment.
- - Use of hematopoietic growth factors within 4 weeks of treatment.
- - Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
- - Prior radiation therapy encompassing >25% of skeleton.
- - Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®) - Platelet count <150,000/mm3 or history of platelet count abnormality or dysfunction.
- - Absolute neutrophil count (ANC) <2,000/mm3 - Hematocrit <30 percent or Hemoglobin < 10 g/dL - Abnormal coagulation profile (PT or INR, PTT) > 1.3x upper limit of normal (ULN) - Serum creatinine > 2x ULN - AST (SGOT) >2.5x ULN - Bilirubin (total) >1.5x ULN - Active serious infection - Active angina pectoris or NY Heart Association Class III-IV - ECOG Performance Status > 2 - Deep vein thrombosis and/or pulmonary embolus within 1 month of enrollment.
- - Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
- - Prior investigational therapy (medications or devices) within 6 weeks of treatment.
- - Known history of HIV.
- - Known leukemia or myelodysplastic syndrome - Prior allergic reaction to Gadolinium contrast.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Weill Medical College of Cornell University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Scott Tagawa, MD|
|Principal Investigator Affiliation||Weill Cornell Medicine|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Kidney Cancer, Head and Neck Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer, Esophageal Cancer, Gliomas|
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Weill Cornell Medical College
New York, New York, 10021
GUONC Research Team