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Study Summary
No. 2008-0058:.......Kidney......Christopher Wood......Urology
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Study Summary Title
Study Summary
Number:		2008-0058
Study 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 (124IcG250)
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Physician New Patient Referral
Name:Christopher WoodPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:UrologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3250
Contact us about clinical trials
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General Information
Disease Group:KidneySupported By:Wilex AG
Phase of Study:Phase IIIReturn
Visit:		Patients will come for Infusion Visit, Safety Visit, Imaging Visit and Surgery.
A Follow Up Visit will be schedule 4-5 weeks after surgery. Approximately 2
months after surgery, a final blood sample (about 1 teaspoon) will be drawn.
Treatment
Agents:		I 124- cG250Home Care: Patient will take potassium iodide tablets by mouth 24 hours prior to
infusion of 124 I-cG250 .This will be followed by 130mg potassium iodide every
day for 14 days and a patient diary will be completed to record when the
potassium iodide is taken
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		Patients who undergo nephrectomy at MD Anderson normally have a
hospitalization of 5 - 7 days.
Description/
Intervention:		The goal of this clinical research study to learn how well a certain type of
image scan, called a positron emission tomography/computed tomography (PET/CT)
scan, can detect clear cell kidney cancer using an experimental drug called 124
I-cG250. The PET/CT scans will then be compared to traditional diagnostic
computed tomography (CT) scans of the same body area.
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Study Objectives / Outcomes
Primary Objective:

1. To compare the sensitivity and specificity of 124 I-cG250 based PET/CT imaging vs. diagnostic CT in the detection of clear cell renal cancer as confirmed by histopathological diagnosis, in patients with operable renal masses.
2. To establish that the sensitivity and specificity of 124 I-cG250 based PET/CT imaging exceed a minimum value of 0.75.

Secondary Objectives:
1. To determine, in patients with operable renal masses, the positive predictive value, the negative predictive value and accuracy of 124 I-cG2501 based PET/CT imaging vs. diagnostic CT in the detection of clear cell renal cancer as confirmed by histopathological diagnosis.
2. To further establish the safety of 124 I-cG250 in patients with renal masses.

Exploratory Objectives:
1. To explore the correlation of 124 I-cG250 PET/CT imaging in the detection of renal cancer with CAIX expression as determined by immunohistochemistry.
2. To explore the ability of 124 I-cG250 PET imaging to detect thoracic and abdominal metastases.
3. To explore the level of agreement between qualitative and semi-quantitative assessment of radiolabel uptake in the lesion during the blinded read.
4. To report the number of cases with multiple lesions and characterize the level of agreement between imaging and pathology in these cases.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:07/25/2008
Study Type:Phase Iii
Recruitment Status:Open
Projected Accrual:210
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Subject is over 18 years of age.

2) Presence of a renal mass.

3) Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique).

4) Expected survival of at least 3 months.

5) ECOG </= 2.

6) The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1: Absolute neutrophil count (ANC) >/= 1.5 x 10(9)/L, Platelet count >/=100 x 10(9)/L, Serum bilirubin </= 2.0 mg/dL, Aspartate aminotransaminase (AST) </= 2.5 x ULN, Alanine aminotransferase (ALT) </= 2.5 x ULN, Serum creatinine </= 2.0 mg/dL (calculated creatinine clearance >45 ml/min).

7) 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.

8) Recovered from toxicity of any prior therapy.

9) Able and willing to give valid written informed consent.
Exclusion Criteria:1) Metastasis of primary tumor other than RCC.

2) Prior history of malignancy within the last 5 years.

3) Prior exposure to murine proteins or chimeric antibodies.

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

5) Intercurrent medical condition that renders the patient ineligible for surgery.

6) New York Heart Association Class III/IV cardiac disease.

7) History of autoimmune hepatitis.

8) Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to (124) I-cG250 infusion on day 1.

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

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

11) Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.

12) Women who are pregnant or breastfeeding.

13) Allergy to iodine, hyperthyroidism, or Grave's Disease.

14) Known allergic reaction to human serum albumin.

15) Contraindication for contrast-enhanced CT or PET/CT.

16) Contraindication to potassium iodide intake.
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Links
Registration Number: NCT00606632
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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