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

NCT01582204 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-08-05

No results posted yet for this study

Summary

Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors. Sometimes, even when a drug is working, it can take several months before the effects are seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called 124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular CT scan.

Research has shown that certain proteins in the blood, called antibodies, can attach themselves to cancer cells without binding to normal cells. In this study, an antibody is used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body, 124I shows up on the PET scan.

Conditions

  • Renal Cancer

Interventions

DRUG

124IcG250

Pts will undergo baseline disease assessment with CT scans (chest, abd \& pelvis), 124I-cG250-PET/CT \& Tc99mMDP bone scan. W/I 7 days of their lst 124I-cG250 PET/CT, pts will start tx with sunitinib or pazopanib, dosed in successive 6-week cycles. At selected time points during the sunitinib or pazopanib cycle 1, repeat imaging with CT scan \& 124I-cG250 PET/CT will be performed. After cycle 2, pts will be followed per standard of care, i.e., pts will have a standard CT scan of the chest, abd, \& pelvis with contrast after cycles 2, 3, 4 \& 6 (or at the time of disease progression if prior to cycle 6) for determination of best response using RECIST 1.1. Each pt will have 2 124I-cG250-PET/CT scans: baseline \& week 4 (during sunitinib or pazopanib tx). All experimental imaging will take place during tx cycle 1. There will be a dosimetry sub-study for pts willing to undergo 3 additional PET/CT scans, whole body counts, \& serial blood sampling, following the lst inj of 124I-cG250.

Sponsors & Collaborators

Principal Investigators

  • Darren Feldman, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582204 on ClinicalTrials.gov