Status:
COMPLETED
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Cancer of Kidney
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.
Detailed Description
Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a fo...
Eligibility Criteria
Inclusion
- Presence of a renal mass.
- Scheduled for surgical resection of renal mass.
- Expected survival of at least 3 months.
- Karnofsky performance scale ≥70.
- The following laboratory results should be within the following limits within the last 4 weeks prior to study day 1:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L
- Platelet count ≥ 100 x 10E9/L
- Serum bilirubin ≤ 2.0 mg/dL
- Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Serum creatinine ≤ 2.0 mg/dL
- Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material.
- Recovered from toxicity of any prior therapy.
- Able and willing to give valid written informed consent.
Exclusion
- 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 the first cG250 dose.
- 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 agent within 4 weeks prior to enrollment.
- Women who are pregnant or breastfeeding.
- Allergy to iodine.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00199888
Start Date
June 1 2005
End Date
May 29 2009
Last Update
October 10 2022
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021