Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
NCT ID: NCT00606632
Last Updated: 2018-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
226 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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124-Iodine-cG250 (124I-cG250)
Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.
124-Iodine-cG250 (124I-cG250)
i.v. and PET/CT scan 4+/-2 days after administration
CT
contrast enhanced CT scan
Interventions
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124-Iodine-cG250 (124I-cG250)
i.v. and PET/CT scan 4+/-2 days after administration
CT
contrast enhanced CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of a renal mass.
* Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique).
* Expected survival of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Serum bilirubin ≤ 2.0 mg/dL
* Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
* Alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Serum creatinine ≤ 2.0 mg/dL (calculated creatinine clearance \>45 ml/min)
* Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. All females of childbearing potential must indicate intent to avoid pregnancy and must use an accepted, effective method of contraception for the duration of the study.
* Recovered from toxicity of any prior therapy.
* Able and willing to give valid written informed consent.
Exclusion Criteria
* Prior history of malignancy within the last 5 years.
* Prior exposure to murine proteins or chimeric antibodies.
* Intercurrent medical condition that may limit the amount of antibody to be administered.
* Intercurrent medical condition that renders the patient ineligible for surgery.
* New York Heart Association Class III/IV cardiac disease.
* History of autoimmune hepatitis.
* Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to 124I-cG250 infusion on day 1.
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
* Lack of availability for immunological and clinical follow-up assessments.
* Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrolment.
* Women who are pregnant or breastfeeding.
* Allergy to iodine, hyperthyroidism, or Grave's Disease.
* Known allergic reaction to human serum albumin.
* Contraindication for contrast-enhanced CT or PET/CT.
* Contraindication to potassium iodide intake (see package insert).
18 Years
ALL
No
Sponsors
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Heidelberg Pharma AG
INDUSTRY
Responsible Party
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Principal Investigators
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Chaitanya Divgi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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David Geffen School of Medicine, UCLA
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
H. Lee Moffitt Cancer Center & Research Center
Tampa, Florida, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
UNC School of Medicine-Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson
Houston, Texas, United States
Countries
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References
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Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gonen M, Ruan S, Pierre C, Nagel A, Pryma DA, Humm J, Larson SM, Old LJ, Russo P. Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses: a phase I trial. Lancet Oncol. 2007 Apr;8(4):304-10. doi: 10.1016/S1470-2045(07)70044-X.
Divgi CR, Uzzo RG, Gatsonis C, Bartz R, Treutner S, Yu JQ, Chen D, Carrasquillo JA, Larson S, Bevan P, Russo P. Positron emission tomography/computed tomography identification of clear cell renal cell carcinoma: results from the REDECT trial. J Clin Oncol. 2013 Jan 10;31(2):187-94. doi: 10.1200/JCO.2011.41.2445. Epub 2012 Dec 3.
Other Identifiers
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WX/20-001
Identifier Type: -
Identifier Source: org_study_id
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