177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors
177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 26, 2009
CompletedFirst Posted
Study publicly available on registry
August 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 2, 2022
February 1, 2022
8.9 years
August 26, 2009
February 1, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change in tumor perfusion as based on Dynamic Contrast Enhanced (DCE)-MRI study
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)
Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
Secondary Outcomes (2)
Changes in response rate using Response evaluation criteria in solid tumors (RECIST) Criteria
Objective response will be evaluated from changes in baseline to Day 99 and repeated every 3 months until radiographic progression of disease.
Change in the number of subjects who achieve Progression Free Survival
Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease
Study Arms (1)
J591
EXPERIMENTALInterventions
70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Tagawa, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2009
First Posted
August 28, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2018
Study Completion
December 31, 2021
Last Updated
February 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share