Renal CancerNCT01582204
Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma
A study testing 124IcG250 in people with Renal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- 124IcG250
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
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.
- Conditions
- Renal Cancer
- Being tested
- 124IcG250
- Keywords
- clear cell carcinoma, Kidney, MAB-124I-CG250, PET scan, CT scan, sunitinib, pazopanib, 11-134
- Medical subject headings
- Kidney Neoplasms, Adenocarcinoma, Clear Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124IcG250Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 124IcG250 | Experimental | 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. Receives: Drug: 124IcG250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of predicting
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.
Measured: 1.5 months
Secondary outcomes (3)
progression-free survival
Prediction of progression-free survival at 9 months as per CT imaging using SUVmax identified on 124I-cG250-PET/CT (at day 24-29).
Measured: 9 months
Detection of metastatic lesions
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)
Measured: 1 year
To evaluate the radiation dosimetry of 124I-cG250.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tarix Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Darren Feldman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582204
- Sponsor's protocol ID
- 11-134
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2012
- Last updated
- 8 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01582204
- Acronym / sponsor ID
- 11-134
- Conditions
- Renal Cancer
- Keywords
- clear cell carcinoma, Kidney, MAB-124I-CG250, PET scan, CT scan, sunitinib, pazopanib, 11-134
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Tarix Pharmaceuticals
- Study start
- Apr 2012
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 124IcG250 | Experimental | Drug: 124IcG250This 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 124IcG250Pts 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. | Drug | 124IcG250 |
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.
3 secondary outcomes
progression-free survival
Time frame: 9 months
Detection of metastatic lesions
Time frame: 1 year
To evaluate the radiation dosimetry of 124I-cG250.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Feldman, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 124IcG250 in people with Renal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of predicting (time frame: 1.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.