Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
Condition: Renal Cell Carcinoma; Kidney Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: 124-Iodine-cG250 (124I-cG250); CT
Intervention description: i.v. and PET/CT scan 4+/-2 days after administration; contrast enhanced CT scan
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

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).