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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: accuracy of predicting [ Time Frame: 1.5 months ]

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.


Original Primary Outcome: accuracy of predicting [ Time Frame: 1.5 months ]

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 as per CT imaging in patients with metastatic and/or advanced ccRCC up through 6 cycles of treatment.


Current Secondary Outcome:

  • progression-free survival [ Time Frame: 9 months ]
    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 ]

    Detection of metastatic lesions at baseline (number, anatomical location, size) comparing CT, PET/CT and bone scan:

    1. Number of metastases detected by CT, PET/CT and bone scan in total
    2. 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 ]
    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.


Original Secondary Outcome:

  • progression-free survival [ Time Frame: 9 months ]
    Prediction of progression-free survival at 9 months as per CT imaging using SUVmax identified on 124I-cG250-PET/CT (at day 25-28 and at day 39-42).
  • Detection of metastatic lesions [ Time Frame: 1 year ]

    Detection of metastatic lesions at baseline (number, anatomical location, size) comparing CT, PET/CT and bone scan:

    1. Number of metastases detected by CT, PET/CT and bone scan in total
    2. Number of metastases detected by CT, PET/CT and bone scan by main metastatic location (local lymph nodes, lung, bone, liver, and other)


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: April 18, 2012
Date Started: April 2012
Date Completion: April 2018
Last Updated: January 10, 2017
Last Verified: January 2017