Status:
COMPLETED
177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Kidney Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 i...
Eligibility Criteria
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.
- 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
- Use of 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) unless on therapeutic anticoagulation
- Serum creatinine \> 2x ULN
- AST (SGOT) \>2.5x ULN
- Bilirubin (total) \>1.5x ULN; subjects with known Gilbert's syndrome are eligible if direct bilirubin is within institutional normal limits
- 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 4 weeks of treatment.
- Known history of HIV.
- Known leukemia or myelodysplastic syndrome
- Prior allergic reaction to Gadolinium contrast.
- Life expectancy \< 3 months
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00967577
Start Date
July 1 2009
End Date
December 31 2021
Last Update
February 2 2022
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10021