Phase 1
N=26
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
Cancer of Kidney · Kidney Cancer · Renal Cancer · Neoplasms, Kidney · Renal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00199888 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
May 2021
Primary outcome: Primary: Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection. — 100 percent of PET-positive patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 124-Iodine-cG250 (124I-cG250) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection. |
100 | — |
| SECONDARY Negative Predictive Value (NPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection. |
90 | — |
| SECONDARY Sensitivity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection. |
94 | — |
| SECONDARY Specificity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection. |
100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00199888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.