Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.

• Status: Completed
• Trial end date: 2009-05-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Collaborator: Memorial Sloan Kettering Cancer Center
• Treatments: Antibodies; Cadexomer iodine; Iodine

Criteria

Inclusion Criteria:

1. Presence of a renal mass.

2. Scheduled for surgical resection of renal mass.

3. Expected survival of at least 3 months.

4. Karnofsky performance scale ≥70.

5. 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

6. Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material.

7. Recovered from toxicity of any prior therapy.

8. Able and willing to give valid written informed consent.

Exclusion Criteria:

1. Intercurrent medical condition that may limit the amount of antibody to be administered.

2. Intercurrent medical condition that renders the patient ineligible for surgery.

3. New York Heart Association Class III/IV cardiac disease.

4. History of autoimmune hepatitis.

5. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250 dose.

6. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.

7. Lack of availability for immunological and clinical follow-up assessments.

8. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.

9. Women who are pregnant or breastfeeding.

10. Allergy to iodine.