Clinical trial NCT00606632: Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Kidney Cancer
Keywords: 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
Lead sponsor: Heidelberg Pharma AG
Sponsor class: INDUSTRY
First posted: 2008-02-04
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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.
* 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:

* Metastasis of primary tumor other than Renal Cell Carcinoma (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).

Primary outcomes:
measure: Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.
timeFrame: 6 months
Secondary outcomes:
measure: Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging
timeFrame: 6 months
measure: Positive Predictive Value (PPV)
timeFrame: 6 months
measure: Negative Predictive Value (NPV)
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine, UCLA
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Center
state: Florida
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine-Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: University of Pennsylvania
name: Chaitanya Divgi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.