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Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody

Primary Purpose

Renal Cell Carcinoma, Kidney Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
124-Iodine-cG250 (124I-cG250)
CT
Sponsored by
Heidelberg Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Cell Carcinoma focused on measuring Renal Mass, Clear Cell Renal Cell Carcinoma, Cancer of Kidney, Kidney Cancer, Neoplasms, cG250, antibody, monoclonal, Iodine 124, Positron-Emission Tomography, Kidney, Renal Cancer, Renal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is over 18 years of age.
  • Presence of a renal mass.
  • Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique).
  • Expected survival of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2.

  • 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 109/L
    • Platelet count ≥ 100 x 109/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)
  • 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.
  • Recovered from toxicity of any prior therapy.
  • Able and willing to give valid written informed consent.

Exclusion Criteria:

  • Metastasis of primary tumor other than Renal Cell Carcinoma (RCC).
  • Prior history of malignancy within the last 5 years.
  • Prior exposure to murine proteins or chimeric antibodies.
  • 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 124I-cG250 infusion on day 1.
  • 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 product within 4 weeks prior to enrolment.
  • Women who are pregnant or breastfeeding.
  • Allergy to iodine, hyperthyroidism, or Grave's Disease.
  • Known allergic reaction to human serum albumin.
  • Contraindication for contrast-enhanced CT or PET/CT.
  • Contraindication to potassium iodide intake (see package insert).

Sites / Locations

  • David Geffen School of Medicine, UCLA
  • Stanford University Medical Center
  • H. Lee Moffitt Cancer Center & Research Center
  • Lahey Clinic
  • University of Michigan
  • Nevada Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • UNC School of Medicine-Chapel Hill
  • Duke University Medical Center
  • Cleveland Clinic Foundation
  • Ohio State University
  • Fox Chase Cancer Center
  • Hospital of the University of Pennsylvania
  • MD Anderson

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

124-Iodine-cG250 (124I-cG250)

Arm Description

Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.

Outcomes

Primary Outcome Measures

Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.
Average estimate of three independent, blinded central readers per imaging modality on the proportion of participants that were correctly identified on the 124I-cG250 PET/CT Images of having (sensitivity) or not having (specificity) clear cell renal carcinoma (ccRCC) compared to CT images. Histopathology provided the standard-of-truth because it is the only definitive method for accurately identifying ccRCC.

Secondary Outcome Measures

Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging
The Accuracy is the proportion of participants with correct determinations of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Positive Predictive Value (PPV)
The Positive Predictive Value (PPV) reflects the Proportion of positive results that are true positive. The PPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Negative Predictive Value (NPV)
Negative Predictive Value (NPV) reflects the proportion of negative results that are true negatives. The NPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.

Full Information

First Posted
January 21, 2008
Last Updated
September 3, 2018
Sponsor
Heidelberg Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00606632
Brief Title
Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
Official 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 (124I-cG250)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heidelberg Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.
Detailed Description
A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Kidney Cancer
Keywords
Renal Mass, Clear Cell Renal Cell Carcinoma, Cancer of Kidney, Kidney Cancer, Neoplasms, cG250, antibody, monoclonal, Iodine 124, Positron-Emission Tomography, Kidney, Renal Cancer, Renal Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
124-Iodine-cG250 (124I-cG250)
Arm Type
Other
Arm Description
Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.
Intervention Type
Drug
Intervention Name(s)
124-Iodine-cG250 (124I-cG250)
Other Intervention Name(s)
Ca9-SCAN
Intervention Description
i.v. and PET/CT scan 4+/-2 days after administration
Intervention Type
Procedure
Intervention Name(s)
CT
Intervention Description
contrast enhanced CT scan
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.
Description
Average estimate of three independent, blinded central readers per imaging modality on the proportion of participants that were correctly identified on the 124I-cG250 PET/CT Images of having (sensitivity) or not having (specificity) clear cell renal carcinoma (ccRCC) compared to CT images. Histopathology provided the standard-of-truth because it is the only definitive method for accurately identifying ccRCC.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging
Description
The Accuracy is the proportion of participants with correct determinations of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Time Frame
6 months
Title
Positive Predictive Value (PPV)
Description
The Positive Predictive Value (PPV) reflects the Proportion of positive results that are true positive. The PPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Time Frame
6 months
Title
Negative Predictive Value (NPV)
Description
Negative Predictive Value (NPV) reflects the proportion of negative results that are true negatives. The NPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is over 18 years of age. Presence of a renal mass. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique). Expected survival of at least 3 months. Eastern Cooperative Oncology Group (ECOG) performance status < 2. 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 109/L Platelet count ≥ 100 x 109/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) 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. Recovered from toxicity of any prior therapy. Able and willing to give valid written informed consent. Exclusion Criteria: Metastasis of primary tumor other than Renal Cell Carcinoma (RCC). Prior history of malignancy within the last 5 years. Prior exposure to murine proteins or chimeric antibodies. 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 124I-cG250 infusion on day 1. 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 product within 4 weeks prior to enrolment. Women who are pregnant or breastfeeding. Allergy to iodine, hyperthyroidism, or Grave's Disease. Known allergic reaction to human serum albumin. Contraindication for contrast-enhanced CT or PET/CT. Contraindication to potassium iodide intake (see package insert).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaitanya Divgi, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Geffen School of Medicine, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1721
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0330
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
UNC School of Medicine-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27711
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17395103
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.
Results Reference
background
PubMed Identifier
23213092
Citation
Divgi CR, Uzzo RG, Gatsonis C, Bartz R, Treutner S, Yu JQ, Chen D, Carrasquillo JA, Larson S, Bevan P, Russo P. Positron emission tomography/computed tomography identification of clear cell renal cell carcinoma: results from the REDECT trial. J Clin Oncol. 2013 Jan 10;31(2):187-94. doi: 10.1200/JCO.2011.41.2445. Epub 2012 Dec 3. Erratum In: J Clin Oncol. 2018 Jan 1;36(1):98.
Results Reference
derived

Learn more about this trial

Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody

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