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

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ClinicalTrials.gov Identifier: NCT00199888
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 30, 2006
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by:
Ludwig Institute for Cancer Research

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date August 30, 2006
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
-Binary reading of 124I-cG250 based PET/CT imaging in renal mass and adjacent normal organ tissues
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00199888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
  • Toxicity defined by NCI Common Toxicity Criteria
  • Radioactivity in renal tumor, adjacent normal organ tissue, and serum indicating uptake of 124I-cG250
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
Official Title  ICMJE Pilot Study of Iodine-124 Labeled Chimeric G250 (124 I-cG250) in Presurgical Patients With Renal Masses
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 blood 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 is that the antibody has tagged.

Monoclonal antibodies are ones 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.

Fifty four patients are expected to be treated in this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cancer of Kidney
  • Kidney Cancer
  • Renal Cancer
  • Neoplasms, Kidney
  • Renal Neoplasms
Intervention  ICMJE Drug: 124-Iodine-cG250 (124I-cG250)
Study Arms  ICMJE Not Provided
Publications * Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gönen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 16, 2005)
54
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 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
  6. Pregnancy Test to be performed on female patients of childbearing potential within 24-48hrs 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00199888
Other Study ID Numbers  ICMJE LUD2002-003
MSKCC IRB#: 05-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ludwig Institute for Cancer Research
Collaborators  ICMJE Memorial Sloan Kettering Cancer Center
Investigators  ICMJE
Principal Investigator: Chaitanya R Divgi, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Pual Russo, MD Memorial Sloan Kettering Cancer Center
PRS Account Ludwig Institute for Cancer Research
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP