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Pilot Study of Iodine-124 Labeled Chimeric G250 (124 I-cG250) in Presurgical Patients With Renal Masses

Phase 1
18 Years
Not Enrolling
Cancer of Kidney, Kidney Cancer, Renal Cancer, Neoplasms, Kidney, Renal Neoplasms

Thank you

Trial Information

Pilot Study of Iodine-124 Labeled Chimeric G250 (124 I-cG250) in Presurgical Patients With Renal Masses

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

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

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

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

-Binary reading of 124I-cG250 based PET/CT imaging in renal mass and adjacent normal organ tissues

Principal Investigator

Chaitanya R Divgi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

June 2006

Related Keywords:

  • Cancer of Kidney
  • Kidney Cancer
  • Renal Cancer
  • Neoplasms, Kidney
  • Renal Neoplasms
  • Kidney Cancer
  • Renal Cancer
  • Neoplasms, Kidney
  • cG250
  • antibody
  • Iodine 124
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021