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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199888
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 30, 2006
Memorial Sloan Kettering Cancer Center
Information provided by:
Ludwig Institute for Cancer Research

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.

Condition or disease Intervention/treatment Phase
Cancer of Kidney Kidney Cancer Renal Cancer Neoplasms, Kidney Renal Neoplasms Drug: 124-Iodine-cG250 (124I-cG250) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Iodine-124 Labeled Chimeric G250 (124 I-cG250) in Presurgical Patients With Renal Masses
Study Start Date : February 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Primary Outcome Measures :
  1. -Binary reading of 124I-cG250 based PET/CT imaging in renal mass and adjacent normal organ tissues

Secondary Outcome Measures :
  1. Toxicity defined by NCI Common Toxicity Criteria
  2. Radioactivity in renal tumor, adjacent normal organ tissue, and serum indicating uptake of 124I-cG250

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00199888

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Chaitanya R Divgi, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Pual Russo, MD Memorial Sloan Kettering Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00199888     History of Changes
Other Study ID Numbers: LUD2002-003
MSKCC IRB#: 05-004
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 30, 2006
Last Verified: August 2006
Keywords provided by Ludwig Institute for Cancer Research:
Kidney Cancer
Renal Cancer
Neoplasms, Kidney
Iodine 124
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cadexomer iodine
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances