177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
Condition: 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
Purpose: The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT00967577
Sponsor: Weill Medical College of Cornell University
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:
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:
Estimated Enrollment: 50
Study Start Date: July 2009
- Age: minimum 18 Years maximum N/A
- Gender: All
- 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.
- 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.
- GUONC Research Team
- Weill Cornell Medical College
- New York New York 10021 United States
View trial on ClinicalTrials.gov