TheranosticTrials.org

Clinical Trial · NCT00967577

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

Overview

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

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1

Contacts

Scott Tagawa, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00967577

Drug / Compound

J591

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Antibodies
Chelator: DOTA

J591

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • 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.
  • Progressive disease manifest by: Development of new lesions or an increase in size of preexisting lesions on imaging study or by physical examination.
  • Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan, CXR and/or bone scan
  • 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.
  • 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

Exclusion

  • Deep vein thrombosis and/or pulmonary embolus within 1 month of enrollment.
  • Platelet count \<150,000/mm3 or history of platelet count abnormality or dysfunction.
  • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
  • Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)
  • AST (SGOT) \>2.5x ULN
  • Prior allergic reaction to Gadolinium contrast.
  • 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.
  • Bilirubin (total) \>1.5x ULN; subjects with known Gilbert's syndrome are eligible if direct bilirubin is within institutional normal limits
  • Serum creatinine \> 2x ULN
  • Abnormal coagulation profile (PT or INR, PTT) \> 1.3x upper limit of normal (ULN) unless on therapeutic anticoagulation
  • Hematocrit \<30 percent or Hemoglobin \< 10 g/dL
  • If alternative treatments are available, metastatic disease should not be progressing so as to anticipate the necessity of urgent treatment within 12 weeks of enrollment based on clinical assessment of the investigator
  • Known history of HIV.
  • Use of hematopoietic growth factors within 4 weeks of treatment.
  • Active serious infection
  • Active angina pectoris or NY Heart Association Class III-IV
  • Use of platelet transfusions within 4 weeks of treatment.
  • Life expectancy \< 3 months
  • ECOG Performance Status \> 2
  • Prior investigational therapy (medications or devices) within 4 weeks of treatment.
  • Absolute neutrophil count (ANC) \<2,000/mm3
  • Prior radiation therapy encompassing \>25% of skeleton.