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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00967577
Recruitment Status : Active, not recruiting
First Posted : August 28, 2009
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE August 26, 2009
First Posted Date  ICMJE August 28, 2009
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE July 2009
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • 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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2009)
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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2009)
Progression free survival [ Time Frame: Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
Official Title  ICMJE 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Cancer
  • Head and Neck Cancer
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Esophageal Cancer
  • Gliomas
Intervention  ICMJE Drug: 177Lu-J591
70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
Other Name: monoclonal antibody J591
Study Arms  ICMJE Experimental: J591
Intervention: Drug: 177Lu-J591
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2009)
20
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00967577
Other Study ID Numbers  ICMJE 0902010212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Tagawa, MD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date February 2020

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