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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00967577
First received: August 26, 2009
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: J591 Drug: 177Lu-J591
70 mCi/m2 of 177Lu-J591 will be administered on Day 1.
Other Name: monoclonal antibody 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 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.

Indium-111 (111In) 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. 111In-J591 is not being given to treat cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967577

Contacts
Contact: Kristen Petrillo, R.N. 212-746-5430 krp9009@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Kristen Petrillo, R.N.    212-746-5430    krp9009@med.cornell.edu   
Principal Investigator: Scott Tagawa, M.D.         
Sub-Investigator: David Nanus, M.D.         
Sub-Investigator: Linda Vahdat, M.D.         
Sub-Investigator: Tessa Cigler, M.D.         
Sub-Investigator: Bryan Schneider, M.D.         
Sub-Investigator: Tsiporah Shore, M.D.         
Sub-Investigator: Allyson Ocean, M.D.         
Sub-Investigator: Elizabeta Popa, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Scott Tagawa, M.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00967577     History of Changes
Other Study ID Numbers: 0902010212
Study First Received: August 26, 2009
Last Updated: March 2, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Diseases
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Kidney Neoplasms
Colorectal Neoplasms
Esophageal Neoplasms
Glioma
Head and Neck Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014