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 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.
- 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 24-29).
- 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)
- To evaluate the radiation dosimetry of 124I-cG250. [ Time Frame: 2 years ] [ Designated as safety issue: No ]using data from patients enrolled in the optional dosimetry sub-study. The data used for this purpose will include PET/CT images, whole-body counts and serum activity measurements. Results will be expressed in terms of absorbed radiation dose per unit administered activity for normal organs.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582204
|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|