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

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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

NCT01582204•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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 study initiation for women of childbearing age and potential.
•Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
•Prior treatment with a VEGF receptor TKI within a time period equivalent to 5 half-lives of the prior TKI (e.g., there should be no substantial amount of TKI remaining in the patient).
•Patient is unable to undergo contrast-enhanced CT.
•Uncontrolled or unstable hyperthyroidism or Grave's Disease.
•Contraindication to IOSATTM intake (see package insert).
•Uncontrolled active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months.
•Unstable cardiac disease, e.g., unstable angina, congestive heart failure or myocardial infarction within the preceding 6 months.
•Known active hepatitis B/C or HIV (human immunodeficiency virus) infection.
•Prior exposure to murine proteins or chimeric antibodies.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

August 5, 2025

Enrollment

ACTUAL participants

Conditions

Renal Cancer

Interventions

124IcG250

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

NCT07227415

Carcinoma, Renal CellAdvanced Renal Cell Carcinoma+11 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

Video Education With Result Dependent dIsclosure

Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders

Stereotactic Magnetic Resonance Guided Radiation Therapy

Planning Operative Strategy Using a Digital Renal Artery Clamping Tool