Andrew Quon
Pre-Surgical Detection of Clear Cell Renal Cell Carcinoma Using Radiolabeled G250-Antibody
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: 124-Iodine-cG250 (124I-cG250)
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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:
o Absolute neutrophil count (ANC) >= 1.5 x 109/L
o Platelet count >= 100 x 109/L
o Serum bilirubin <= 2.0 mg/dL
o Aspartate aminotransaminase (AST) <= 2.5 x ULN
o Alanine aminotransferase (ALT) <= 2.5 x ULN
o 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.
Key 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).
Additional Study Details
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)Anticipated start date:
10/15/2008Lead Sponsor:
Wilex AGInvestigator(s):
Study Type:
InterventionalPurpose:
DiagnosticAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Reading of diagnostic CT imaging in renal masses to decide on the presence or absence of ccRCC
- 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.
Secondary Outcomes:
- Safety evaluation of 124I -cG250 in patients with renal masses
Total Number to be Enrolled:
166Total Number to be Enrolled at Stanford:
15More Information
Secondary ID(s):
- NCT00606632
- RENAL0018
- WX/20-001
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/29/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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