Cancer of KidneyPhase 1NCT00199888
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
A Phase 1 study testing 124-Iodine-cG250 (124I-cG250) in people with Cancer of Kidney and Kidney Cancer, run by Ludwig Institute for Cancer Research at 1 site in United States.
Trial summary
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Kidney, Kidney Cancer, Renal Cancer
- What is being tested?
- 124-Iodine-cG250 (124I-cG250)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to 29 May 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Presence of a renal mass.
- Scheduled for surgical resection of renal mass.
- Expected survival of at least 3 months.
- Karnofsky performance scale ≥70.
- The following laboratory results should be within the following limits within the last 4 weeks prior to study day 1:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L
Show all 14Show fewer
- Platelet count ≥ 100 x 10E9/L
- Serum bilirubin ≤ 2.0 mg/dL
- Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Serum creatinine ≤ 2.0 mg/dL
- Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material.
- Recovered from toxicity of any prior therapy.
- Able and willing to give valid written informed consent.
Who cannot join
- Intercurrent medical condition that may limit the amount of antibody to be administered.
- Intercurrent medical condition that renders the patient ineligible for surgery.
- New York Heart Association Class III/IV cardiac disease.
- History of autoimmune hepatitis.
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250 dose.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Show all 10Show fewer
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Women who are pregnant or breastfeeding.
- Allergy to iodine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Pilot Study of Iodine-124 Labeled Chimeric G250 (124I-cG250) in Presurgical Patients With Renal Masses
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.
Read the detailed description
Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy whatever the antibody has tagged.
Monoclonal antibodies are antibodies that can be made in the lab. They tag a portion of a cancer cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an antibody response in humans after one dose. Now they are more like human antibodies, and thus, do not produce the same reactions on repeated doses. These are called chimeric antibodies. The antibody we will use in this study is called chimeric G250 (cG250).
Recent research has shown that some antibodies can attach themselves to cancer cells, and that they bind to very few normal cells. This could help cancer treatment in two ways. One is that the body's own immune system might work to destroy tagged cancer cells. The other is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These can then deliver treatment when the antibodies attach to the cancer cells.
This study is being done to test the tagging ability of cG250 to cancer cells. After you receive cG250, you will have a scan. The picture the scan produces will show where the antibody has collected inside the body. From this, it is possible to measure how well cG250 can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we will examine the tumor and other tissue to see how much of the antibody has attached to the tumor.
- Conditions
- Cancer of Kidney, Kidney Cancer, Renal Cancer, Neoplasms, Kidney, Renal Neoplasms, Renal Cell Carcinoma (RCC)
- Being tested
- 124-Iodine-cG250 (124I-cG250)
- Keywords
- Kidney Cancer, Renal Cancer, Neoplasms, Kidney, cG250, antibody, Iodine 124
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124-Iodine-cG250 (124I-cG250)Drug
| Study group | Role | What they receive |
|---|---|---|
| 124I-cG250 | Experimental | Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once immediately prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8. Receives: Drug: 124-Iodine-cG250 (124I-cG250) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of > 3 and PET-negative if less than or equal to 3.
The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.
PPV is the proportion of patients with a positive PET scan who actually have the disease based on pathology. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have negative PET scans on imaging and non-clear cell RCC on pathology will be considered true-negatives. Patients with positive PET scans on imaging and non-clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Measured: 8 days
Secondary outcomes (3)
Negative Predictive Value (NPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of > 3 and PET-negative if less than or equal to 3.
The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.
NPV is the ratio of participants who do not have clear cell RCC to all those who had negative PET scans.
Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Measured: 8 days
Sensitivity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of > 3 and PET-negative if less than or equal to 3.
The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.
Sensitivity is defined as the ratio of the proportion of the patients who have clear cell RCC based on pathology and whose PET scans are positive over the number of patients with clear cell RCC. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Measured: 8 days
Specificity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of > 3 and PET-negative if less than or equal to 3.
The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.
Specificity is defined as the number of patients with non-clear cell RCC correctly classified divided by all non-clear cell RCC patients.
Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered a true-positive. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2006
- Study completion29 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of KidneyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Chaitanya R Divgi, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterPual Russo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199888
- Sponsor's protocol ID
- LUD2002-003
- Other IDs
- MSKCC IRB#: 05-004
- Status last verified
- Oct 2022
- First submitted
- 13 Sep 2005
- Last updated
- 10 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gonen M, Ruan S, Pierre C, Nagel A, Pryma DA, Humm J, Larson SM, Old LJ, Russo P. Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses: a phase I trial. Lancet Oncol. 2007 Apr;8(4):304-10. doi: 10.1016/S1470-2045(07)70044-X.
PubMed 17395103
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Iodine-124 Labeled Chimeric G250 (124I-cG250) in Presurgical Patients With Renal Masses
- ClinicalTrials.gov ID
- NCT00199888
- Acronym / sponsor ID
- LUD2002-003
- Conditions
- Cancer of Kidney, Kidney Cancer, Renal Cancer, Neoplasms, Kidney, Renal Neoplasms, Renal Cell Carcinoma (RCC)
- Keywords
- Kidney Cancer, Renal Cancer, Neoplasms, Kidney, cG250, antibody, Iodine 124
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ludwig Institute for Cancer ResearchUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- Jun 2005 (actual)
- Primary completion
- Mar 2006 (actual)
- Study completion
- 29 May 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.
Detailed description
Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy whatever the antibody has tagged.
Monoclonal antibodies are antibodies that can be made in the lab. They tag a portion of a cancer cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an antibody response in humans after one dose. Now they are more like human antibodies, and thus, do not produce the same reactions on repeated doses. These are called chimeric antibodies. The antibody we will use in this study is called chimeric G250 (cG250).
Recent research has shown that some antibodies can attach themselves to cancer cells, and that they bind to very few normal cells. This could help cancer treatment in two ways. One is that the body's own immune system might work to destroy tagged cancer cells. The other is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These can then deliver treatment when the antibodies attach to the cancer cells.
This study is being done to test the tagging ability of cG250 to cancer cells. After you receive cG250, you will have a scan. The picture the scan produces will show where the antibody has collected inside the body. From this, it is possible to measure how well cG250 can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we will examine the tumor and other tissue to see how much of the antibody has attached to the tumor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 124I-cG250 | Experimental | Drug: 124-Iodine-cG250 (124I-cG250)Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once immediately prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Presence of a renal mass.
- Scheduled for surgical resection of renal mass.
- Expected survival of at least 3 months.
- Karnofsky performance scale ≥70.
- The following laboratory results should be within the following limits within the last 4 weeks prior to study day 1:
Key exclusion criteria (10 listed)
- Intercurrent medical condition that may limit the amount of antibody to be administered.
- Intercurrent medical condition that renders the patient ineligible for surgery.
- New York Heart Association Class III/IV cardiac disease.
- History of autoimmune hepatitis.
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250 dose.
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 |
|---|---|---|
| 124-Iodine-cG250 (124I-cG250) | Drug | 124I-cG250 |
Primary outcome
Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Time frame: 8 days
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of > 3 and PET-negative if less than or equal to 3. The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made. PPV is the proportion of patients with a positive PET scan who actually have the disease based on pathology. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have negative PET scans on imaging and non-clear cell RCC on pathology will be considered true-negatives. Patients with positive PET scans on imaging and non-clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
3 secondary outcomes
Negative Predictive Value (NPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Time frame: 8 days
Sensitivity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Time frame: 8 days
Specificity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
Time frame: 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17395103Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gonen M, Ruan S, Pierre C, Nagel A, Pryma DA, Humm J, Larson SM, Old LJ, Russo P. Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses: a phase I trial. Lancet Oncol. 2007 Apr;8(4):304-10. doi: 10.1016/S1470-2045(07)70044-X.
- Individual participant dataSharing planned: No
Related trials for Cancer of Kidney
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Chaitanya R Divgi, MD principal investigator
Memorial Sloan Kettering Cancer Center
Pual Russo, 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 Phase 1 study testing 124-Iodine-cG250 (124I-cG250) in people with Cancer of Kidney and Kidney Cancer, run by Ludwig Institute for Cancer Research 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: finished, as of the sponsor's last update on 10 Oct 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection. (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00199888, which also lists 1 linked publication.
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 10 Oct 2022.