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

Study Overview

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

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

177Lu-J591 is made up of two compounds called J591 and 177Lutetium (177Lu) that are joined together by a connecting molecule called ȭOTA". 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.

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

0902010212

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-08-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-02-01
First Submitted that Met QC Criteria 2009-08-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-02-02
First Posted (ACTUAL) 2009-08-28	Results First Posted N/A	Last Verified 2022-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: J591	DRUG: 177Lu-J591 70 mCi/m2 of 177Lu-J591 will be administered on Day 1.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: J591

DRUG: 177Lu-J591

70 mCi/m2 of 177Lu-J591 will be administered on Day 1.

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Changes in response rate using Response evaluation criteria in solid tumors (RECIST) Criteria	Through RECIST criteria, objective response will be evaluated by taking into account the measurement of the longest diameter only for all target lesions on CT scans as well as normalization of serum tumor markers (if applicable).	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	Progression free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. This will be calculated from the time of treatment (day of 177Lu-J591 infusion) until radiographic progression or death.	Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Scott Tagawa, MD, Weill Medical College of Cornell University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

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Caregivers

Clinical Trial Record