Clinical Trials /

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

NCT00967577

Description:

The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
  • Official Title: 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study

Clinical Trial IDs

  • ORG STUDY ID: 0902010212
  • NCT ID: NCT00967577

Conditions

  • Kidney Cancer
  • Head and Neck Cancer
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Esophageal Cancer
  • Gliomas

Interventions

DrugSynonymsArms
177Lu-J591monoclonal antibody J591J591

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
J591Experimental
  • 177Lu-J591

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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.
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression free survival
Time Frame:Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease.
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Weill Medical College of Cornell University

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