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Pre-Surgical Detection of Clear Cell Renal Cell Carcinoma Using Radiolabeled G250-Antibody
This study is currently recruiting participants.
Verified by Wilex, October 2008
First Received: January 21, 2008   Last Updated: June 2, 2009   History of Changes
Sponsored by: Wilex
Information provided by: Wilex
ClinicalTrials.gov Identifier: NCT00606632
  Purpose

This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.


Condition Intervention Phase
Renal Cell Carcinoma
Kidney Cancer
Drug: 124-Iodine-cG250 (124I-cG250)
Phase III

Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Comparative Study of PET/CT Versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-Surgical Patients With Renal Masses Using Iodine-124 Labeled Chimeric G250 (124I-cG250)

Resource links provided by NLM:


Further study details as provided by Wilex:

Primary Outcome Measures:
  • Binary qualitative reading of 124I-cG250 based PET/CT imaging in renal masses and adjacent normal organ tissues to decide on the presence or absence of ccRCC. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reading of diagnostic CT imaging in renal masses to decide on the presence or absence of ccRCC. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety evaluation of 124I -cG250 in patients with renal masses [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 166
Study Start Date: March 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 124-Iodine-cG250 (124I-cG250)
    i.v.
Detailed Description:

A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.

  Eligibility

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

Inclusion Criteria:

  • Subject is over 18 years of age.
  • 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.
  • ECOG < 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:

  • Metastasis of primary tumor other than RCC.
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606632

Contacts
Contact: Roman Bartz, Dr. +49 89 413 138 ext 52 roman.bartz@wilex.com

Locations
United States, California
David Geffen School of Medicine, UCLA Recruiting
Los Angeles, California, United States, 90095-1721
Principal Investigator: Allan Pantuck, MD            
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Principal Investigator: Benjamin Chung, MD            
United States, Florida
H. Lee Moffitt Cancer Center & Research Center Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Wade Sexton, MD            
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Principal Investigator: John Libertino, MD            
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-0330
Principal Investigator: Khaled Hafez, MD            
United States, Nevada
Nevada Cancer Institute Recruiting
Las Vegas, Nevada, United States, 89135
Principal Investigator: Nicholas Vogelzang, MD            
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Principal Investigator: Steven Larson, MD            
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27711
Principal Investigator: Thomas Polascik, MD            
UNC School of Medicine-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Arif Sheikh, MD            
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Steve Campbell, MD            
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Robert Bahnson, MD            
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Principal Investigator: Daniel Pryma, MD            
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Principal Investigator: David Chen, MD            
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030-4009
Principal Investigator: Christopher Wood, MD            
Sponsors and Collaborators
Wilex
Investigators
Principal Investigator: Chaitanya Divgi, MD University of Pennsylvania
  More Information

Publications:
Responsible Party: Wilex ( Roman Bartz )
Study ID Numbers: WX/20-001
Study First Received: January 21, 2008
Last Updated: June 2, 2009
ClinicalTrials.gov Identifier: NCT00606632     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Wilex:
Renal Mass
Clear Cell Renal Cell Carcinoma
Cancer of Kidney
Kidney Cancer
Neoplasms
cG250
antibody, monoclonal
Iodine 124
Positron-Emission Tomography
Kidney
Renal Cancer
Renal Neoplasms

Study placed in the following topic categories:
Anti-Infective Agents
Urinary Tract Neoplasm
Kidney Cancer
Trace Elements
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Antibodies, Monoclonal
Anti-Infective Agents, Local
Antibodies
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Clear Cell Renal Cell Carcinoma
Iodine
Micronutrients
Kidney Diseases
Adenocarcinoma
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Growth Substances
Physiological Effects of Drugs
Trace Elements
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Iodine
Micronutrients
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 03, 2009