Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Trial To Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma|
- accuracy of predicting [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]The primary endpoint will be the accuracy of predicting response as per 124I-cG250- PET/CT (based on patient SUVs at day 25-28 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.
- progression-free survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]Prediction of progression-free survival at 9 months as per CT imaging using SUVmax identified on 124I-cG250-PET/CT (at day 25-28).
- Detection of metastatic lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Detection of metastatic lesions at baseline (number, anatomical location, size) comparing CT, PET/CT and bone scan:
- Number of metastases detected by CT, PET/CT and bone scan in total
- Number of metastases detected by CT, PET/CT and bone scan by main metastatic location (local lymph nodes, lung, bone, liver, and other)
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
This is a pilot study of 124I-cG250-PET/CT in 25 evaluable patients with advanced and/or metastatic clear cell renal cell carcinoma (ccRCC) who are scheduled to begin treatment with sunitinib or pazopanib. 124I-cG250-PET/CT will be assessed for its ability to predict response in comparison to standard CT scan of the chest, abdomen, and pelvis.
Prior to enrollment, all pts will have screening procedures performed to establish their eligibility for the study (day -28 - day -14), including baseline diagnostic CT and bone scan. On day -14 - day -10, patients will receive an injection of 124I-cG250. To reduce uptake of radioactive iodine in the thyroid, patients will take an oral dose of potassium iodide (IOSATTM, Anbex Inc., or utilize institutional inorganic iodine protection guidelines) daily. Self-administration of potassium iodide will commence at 12-24 hours prior to all 124I-cG250 administrations and continue for a total of 14 days. Patients will document date and time of potassium iodide in a diary that will be submitted to the research staff. Pts will undergo PET imaging 5 ± 1 days after injection of 124I-cG250. Treatment with sunitinib or pazopanib will then start within 7 days of completion of baseline imaging. Sunitinib or pazopanib will be administered in 6-week cycles (4 weeks on treatment, 2 weeks off treatment).
|Contact: Steven Larson, MD||212-639-7373|
|Contact: Neeta Pandit-Taskar||212-639-3046|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Steven M. Larson, MD 212-639-7373|
|Contact: Neeta Pandit-Taskar, MD 212-639-3046|
|Principal Investigator: Steven Larson, MD|
|Principal Investigator:||Steven Larson, MD||Memorial Sloan-Kettering Cancer Center|