Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients Wit… (NCT01582204) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma
United States17 participantsStarted 2012-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed clear cell carcinoma (conventional) with advanced and/or metastatic disease.
* Radiographic evidence of unidimensionally measurable disease. Lesions will be considered measurable or non- measurable as per definitions provided in RECIST version 1.1
* Subjects must be planned for treatment with approved treatment doses of a VEGF receptor TKI (e.g., sunitinib, pazopanib, cabozantinib, axitinib, sorafenib, lenvatinib).
* Male or female, 18 years of age or older.
* ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2.
* Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade ≤2.
* The following laboratory results should be within the following limits, within 2 weeks prior to study start:
* Absolute neutrophil count (ANC) ≥1.5 x 109/L
* Total serum bilirubin \<2.0 mg/dL
* Platelets ≥100,000/μL
* Serum creatinine ≤2.0 mg/dL
* Aspartate aminotransaminase (AST) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)
* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets)
* Valid written informed consent signed by the patient prior to any study-specific procedures.
Exclusion Criteria:
* Women who are pregnant or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. A negative pregnancy test is required within 24 hours of administration of radiotracer and s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.