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Pilot Trial To Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma

18 Years
Open (Enrolling)
Renal Cancer

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Trial Information

Pilot Trial To Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma

Inclusion Criteria:

- Histologically confirmed clear cell carcinoma (conventional) with advanced and/or
metastatic disease.

- Radiographic evidence of unidimensionally measurable disease with at least one lesion
≥2.0 cm in diameter on 16-slice multi-detector CT scan of the chest, abdomen, and
pelvis. Lesions will be considered measurable or non- measurable as per definitions
provided in RECIST version 1.1

- Subjects must be planned for treatment with approved treatment doses of sunitinib or

- Male or female, 18 years of age or older.

- ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2.

- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or
surgical procedure to NCI CTCAE grade ≤2.

- The following laboratory results should be within the following limits, within 2
weeks prior to study start:

- Absolute neutrophil count (ANC) ≥1.5 x 109/L

- Total serum bilirubin <2.0 mg/dL

- Platelets ≥100,000/μL

- Serum creatinine ≤2.0 mg/dL

- Aspartate aminotransaminase (AST) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)

- Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)

- Valid written informed consent signed by the patient prior to any study-specific

Exclusion Criteria:

- Women who are pregnant or breast-feeding. Female patients must be surgically sterile
or be postmenopausal, or must agree to use effective contraception during the period
of therapy. A negative pregnancy test is required within 24 hours of administration
of radiotracer and study initiation for women of childbearing age and potential.

- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and
in the judgment of the investigator would make the patient inappropriate for entry
into this study.

- Prior treatment with sunitinib or pazopanib within the past 4 weeks or at any time of
greater than 6 weeks duration.

- Patient is unable to undergo contrast-enhanced CT.

- Uncontrolled or unstable hyperthyroidism or Grave's Disease.

- Contraindication to IOSATTM intake (see package insert).

- Contraindication to sunitinib or pazopanib treatment.

- Uncontrolled active seizure disorder or history of cerebrovascular accident (CVA) or
transient ischemic (TI) attack within the past 12 months.

- Unstable cardiac disease, e.g., unstable angina, congestive heart failure or
myocardial infarction within the preceding 6 months.

- Known active hepatitis B/C or HIV (human immunodeficiency virus) infection.

- Prior exposure to murine proteins or chimeric antibodies.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

accuracy of predicting

Outcome Description:

The primary endpoint will be the accuracy of predicting response as per 124I-cG250- PET/CT (based on patient SUVs at day 24-29 and at day 39-42, separately) for early detection of best response to sunitinib or pazopanib as per CT imaging in patients with metastatic and/or advanced ccRCC up through 6 cycles of treatment.

Outcome Time Frame:

1.5 months

Safety Issue:


Principal Investigator

Steven Larson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

April 2014

Related Keywords:

  • Renal Cancer
  • clear cell carcinoma
  • Kidney
  • MAB-124I-CG250
  • PET scan
  • CT scan
  • sunitinib
  • pazopanib
  • 11-134
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



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