Clinical trial NCT00199888: Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
Official title: Pilot Study of Iodine-124 Labeled Chimeric G250 (124I-cG250) in Presurgical Patients With Renal Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer of Kidney
Kidney Cancer
Renal Cancer
Neoplasms, Kidney
Renal Neoplasms
Renal Cell Carcinoma (RCC)
Clear Cell Renal Cell Carcinoma
Keywords: Kidney Cancer
Renal Cancer
Neoplasms, Kidney
cG250
antibody
Iodine 124
Lead sponsor: Ludwig Institute for Cancer Research
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2005-09-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy whatever the antibody has tagged.

Monoclonal antibodies are antibodies that can be made in the lab. They tag a portion of a cancer cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an antibody response in humans after one dose. Now they are more like human antibodies, and thus, do not produce the same reactions on repeated doses. These are called chimeric antibodies. The antibody we will use in this study is called chimeric G250 (cG250).

Recent research has shown that some antibodies can attach themselves to cancer cells, and that they bind to very few normal cells. This could help cancer treatment in two ways. One is that the body's own immune system might work to destroy tagged cancer cells. The other is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These can then deliver treatment when the antibodies attach to the cancer cells.

This study is being done to test the tagging ability of cG250 to cancer cells. After you receive cG250, you will have a scan. The picture the scan produces will show where the antibody has collected inside the body. From this, it is possible to measure how well cG250 can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we will examine the tumor and other tissue to see how much of the antibody has attached to the tumor.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 8 days
Secondary outcomes:
measure: 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.
timeFrame: 8 days
measure: 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.
timeFrame: 8 days
measure: 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.
timeFrame: 8 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Chaitanya R Divgi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Pual Russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gonen M, Ruan S, Pierre C, Nagel A, Pryma DA, Humm J, Larson SM, Old LJ, Russo P. Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses: a phase I trial. Lancet Oncol. 2007 Apr;8(4):304-10. doi: 10.1016/S1470-2045(07)70044-X.