NCT01582204

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2012-04-20
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States