177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Weill Medical College of Cornell University
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
First received: August 26, 2009
Last updated: May 4, 2015
Last verified: May 2015

August 26, 2009
May 4, 2015
July 2009
December 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00967577 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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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
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.

Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
Other Name: monoclonal antibody J591
Experimental: J591
Intervention: Drug: 177Lu-J591
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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. This will include, but is not limited to patients with cancers of the kidney, urothelium, head and neck, breast, non-small cell lung, colorectal, pancreas, ovary, esophagus and gliomas.
  • 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. Females of child-bearing potential must have a negative pregnancy test.

Exclusion Criteria:

  • 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.
18 Years and older
Contact: Lauren Emmerich, R.N. 212-746-1851 lae9024@med.cornell.edu
United States
Scott Tagawa, M.D., Weill Cornell Medical College
Weill Medical College of Cornell University
Not Provided
Not Provided
Weill Medical College of Cornell University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP