Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoconjugates

Immunoglobulins

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.2 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.3 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.4 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.45 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.55 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients received a single infusion of \^90Y-DOTA-cG250, with escalating doses administered to sequentially enrolled cohorts until MTD determination.

Yttrium-90 conjugated chimeric G250 (^90Y-DOTA-cG250)

Steven Larson, MD

Neeta Pandit-Taskar, MD

Joseph O'Donoghue, PhD

Robert Motzer, MD

This was a Phase 1, open-label, dose-escalation study of yttrium-90 conjugated chimeric G250 (\^90Y-DOTA-cG250) in patients with advanced, measurable clear cell renal cell carcinoma (RCC). Study objectives were to determine the safety, targeting, and dosimetry of \^90Y-DOTA-cG250, using indium-111 conjugated chimeric G250 (\^111In-DOTA-cG250) as a surrogate, as well as to evaluate the immunogenicity of cG250.

Patients were enrolled sequentially into cohorts of 3 to 6 patients until determination of the maximum tolerated dose (MTD) of \^90Y-DOTA-cG250, defined as the dose level below the dose at which ≥ 2 patients experienced dose-limiting toxicity (DLT). In an attempt to mitigate liver uptake and toxicity, patients initially received a nontherapeutic injection with \^111In-DOTA-cG250 at an imaging dose of 5 mCi of \^111In + 10 mg of cG250 on Day 1. Whole body and blood measurements of radioactivity were obtained on at least 3 occasions for 1 week to determine targeting and dosimetry. Provided that protocol-specified criteria were met, including targeting to lesions \> 2 cm detected on computed tomography (CT) scan, a single dose of therapeutic \^90Y-DOTA-cG250 was administered on Day 8, 9, or 10. The starting dose of \^90Y-DOTA-cG250 was 0.2 mCi/kg of \^90Y + 10 mg of cG250 administered as an intravenous (IV) infusion, with escalation of the \^90Y dose in subsequent cohorts in 0.05 to 0.1 mCi/kg increments.

Patients were treated in an outpatient setting and were observed for at least 2 hours following each infusion, at which point vital signs and blood samples were obtained. Patients were followed for 6 to 8 weeks post-treatment (or after recovery from toxicity) with imaging, biochemical, serological, and hematologic tests to determine the safety of \^90Y-DOTA-cG250 and to inform dose-escalation decisions. Extent of disease evaluations, preferably by positron emission tomography (PET)/CT or standard CT, were performed at baseline and 6 to 8 weeks post-treatment (or after recovery from toxicity). Long-term follow-up was performed, when possible, every 12 weeks thereafter for up to 2 years.

Patients were enrolled sequentially in cohorts of 3 to 6 patients to receive escalating doses of study treatment until determination of the MTD.

Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250

Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (^90Y-DOTA-cG250) in Patients With Advanced Renal Cancer

Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as follows for the purposes of dose escalation: Grade 4 hematopoietic toxicity in excess of 5 days or Grade 3 or greater nonhematopoietic toxicity.

In order to receive the therapeutic \^90Y-DOTA-cG250 injection on Day 8, 9, or 10, patients must have demonstrated tumor targeting to lesions \> 2 cm detected by CT scan and must not have exhibited the following characteristics following the nontherapeutic injection of \^111In-DOTA-cG250: excessive liver and/or spleen uptake; excessive uptake in the normal kidney; non-visualization of the cardiac blood pool in the first imaging set; whole body clearance half-life (t1/2) \< 1.5 days; serum t1/2 \< 2 days; rapid clearance of the radiopharmaceutical from the blood pool with prominent marrow uptake on the first image.

Blood samples were drawn for evaluation of the human antichimeric antibody (HACA) at screening, between Days 22 and 28, between Days 36 and 42, between Days 43 and 57 or at the end of study, and during long-term follow-up (approximately 12 weeks later). Serial dilutions were tested by the enzyme-linked immunosorbent assay (ELISA) using the "double antibody sandwich" technique and pretreatment serum as negative control.

Memorial Sloan Kettering Cancer Center

Ludwig Institute for Cancer Research

AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per patient at the maximum reported grade.

Cohort 1 (0.2 mCi/kg)

Cohort 2 (0.3 mCi/kg)

Cohort 3 (0.4 mCi/kg)

Cohort 4 (0.45 mCi/kg)

Cohort 5 (0.55 mCi/kg)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Missing

Higher performance status indicates higher functional abilities, as follows:

100=Normal, no complaints/evidence of disease. 90=Able to carry on normal activity; minor signs/symptoms of disease. 80=Normal activity with effort; some signs/symptoms of disease. 70=Cares for self; unable to carry on normal activity or do active work. 60=Requires occasional assistance but is able to care for most personal needs. 50=Requires considerable assistance \& frequent medical care. 0-40=Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly.

Karnofsky Performance Status

The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.

Jonathan Skipper PhD

Any TEAE

Maximum grade 1 TEAE

Maximum grade 2 TEAE

Maximum grade 3 TEAE

Maximum grade 4 TEAE

Treatment-related TEAE

Serious TEAE

TEAE Leading to Treatment Discontinuation

TEAE Meeting DLT Criteria

Number of Patients With Treatment-emergent Adverse Events

Number of Patients Who Met Protocol-Specified Criteria to Receive ^90-Y-DOTA-cG250 Following ^111In-DOTA-cG250 Administration

Baseline

Day 28

Day 42

Day 63

Long-term Follow-up

Number of Patients With Samples Collected for Evaluation of Human Antichimeric Antibody

Overall Study

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Chelating Agents

Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m\^2 of 177-Lu.

Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m\^2 of 177-Lu.

Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m\^2 of 177-Lu.

Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m\^2 of 177-Lu.

Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m\^2 of 177-Lu.

Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m\^2 of 177-Lu.

On Day 1, each subject received a single intravenous (IV) infusion of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

111-In-DOTA-cG250

On Day 8, 9, or 10, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.

177-Lu-DOTA-cG250

W.J.G. Oyen, MD

P.F.A. Mulders, MD

This was a Phase I/II, single-center, dose-escalation study. 177-Lutetium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-cG250 (177-Lu-DOTA-cG250) was administered at a starting dose of 30 mCi/m\^2 of 177-Lu (fixed dose of 10 mg cG250) and escalated in increments of 10 mCi/m\^2 of 177-Lu in sequentially enrolled cohorts according to a standard 3 + 3 design until determination of the maximum tolerated dose (MTD). The primary objectives were to determine the safety, targeting, and dosimetry of 177-Lu-DOTA-cG250 in subjects with advanced renal cell carcinoma. The secondary objective was measurement of tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Prior to administration of 177-Lu-DOTA-cG250, subjects received 5 mCi/10 mg of the 111-Indium-DOTA-cG250 (111-In-DOTA-cG250) antibody (an imaging dose). Whole body and blood measurements of radioactivity were obtained on at least 3 occasions for 1 week to determine targeting and dosimetry. If at least one known and evaluable metastatic lesion was visualized with 111-In-DOTA-cG250, a single dose of therapeutic 177-Lu-DOTA-cG250 was administered the following week. In the absence of disease progression and after recovery from toxicity, subjects may have been retreated no sooner than 12 weeks after the previous treatment with a dose of no more than 75% of the previous dose, for a total of not more than 3 treatments. Only subjects with normal pharmacokinetics on the diagnostic 111-In-DOTA-cG250 study (indicative of human anti-chimeric antibody \[HACA\] negativity) were eligible for re-treatment.

Subjects in the initial cohort were enrolled sequentially to receive 30 mCi/m\^2 of 177-Lu-DOTA-cG250 (fixed dose of 10 mg cG250). In the absence of a dose-limiting toxicity, the dose was escalated in each subsequent cohort in 10 mCi/m\^2 increments of 177-Lu. At least 3 subjects per dose level were followed for up to 12 weeks with imaging, biochemical, and hematologic tests. Safety was monitored continuously throughout the study.

Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer

Phase I/II Study of Increasing Doses of Lutetium-177 Labeled Chimeric Monoclonal Antibody cG250 (177^Lu-DOTA-cG250) in Patients With Advanced Renal Cancer

Toxicity was graded in accordance with the NCI CTCAE version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.

Subjects were monitored for AEs for ≥ 8 weeks after the last infusion of 177-Lu-DOTA-cG250 before dose escalation could be implemented. Toxicity was graded in accordance with the NCI CTCAE version 3.0. DLT was defined as the following treatment-related events: ≥ Grade 3 non-hematologic toxicity; ≥ Grade 4 hematologic toxicity (platelets \< 25 × 10\^9/L or leukocytes \< 1.0 × 10\^9/L) that persisted for \> 4 weeks except anemia; thrombocytopenia \< 10 × 10\^9/L; clinically relevant myelotoxicity that required hospitalization and/or blood product transfusion (e.g., uncontrolled bleeding, infections that had to be treated clinically).

After each 177-Lu-cG250 administration, 3 whole-body scintigrams were acquired (directly after injection and 2-4 days and 5-7 days post-injection) and blood samples were drawn at 5, 30, 60, and 120 min, 2-4 days, and 5-7 days post-infusion. Estimated radiation absorbed doses were calculated according to the Medical Internal Radiation Dose scheme, which permits estimation of the factors required to calculate dose to one organ attributable to a source in another organ.

Tumor responses were evaluated using computed tomography and categorized according to RECIST v1.0 at baseline and at the end of every cycle (every 12 weeks) or after recovery from toxicity. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.

Radboud University Medical Center

AE documentation included onset/resolution dates, severity using NCI CTCAE (v3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m\^2 of 177-Lu.

Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m\^2 of 177-Lu.

Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m\^2 of 177-Lu.

Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m\^2 of 177-Lu.

Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m\^2 of 177-Lu.

Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m\^2 of 177-Lu.

Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250

111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.

177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m\^2 of 177-Lu.

Netherlands

Body Mass Index

The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.

Maximum Grade 3 TEAE

Maximum Grade 4 TEAE

Death

TEAE Leading to Discontinuation

Number of Subjects With Treatment-emergent Adverse Events

Any DLT

Grade 4 Thrombocytopenia

Grade 4 Leukopenia

Grade 4 Neutropenia

Grade 3 Epistaxis

Grade 3 Fatigue

Grade 3 Hematoma

Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1

Whole Body

Liver

Heart Wall

Red Marrow (Image-based)

Red Marrow (Blood-based)

Kidney

Lungs

Testes

Metastases

Dosimetry Evaluable Analysis Set

The Dosimetry Evaluable Analysis Set comprises all subjects who received at least 1 dose of 177-Lu-cG250.

Radiation Absorbed Doses by Organ for 177-Lu-cG250

Cycle 1: Stable Disease

Cycle 1: Progressive Disease

Cycle 2: Partial Response

Cycle 2: Stable Disease

Cycle 2: Progressive Disease

Cycle 3: Stable Disease

Cycle 3: Progressive Disease

The Evaluable Analysis Set comprises subjects who completed Cycle 1 (ie, received both 111-In-DOTA-cG250 and 177-Lu-DOTA-cG250) and had at least 1 post-baseline response assessment. The Evaluable Analysis Set includes 23 subjects who completed Cycle 1, 12 subjects who completed Cycle 2, and 4 subjects who completed Cycle 3.

Number of Subjects With Best Overall Tumor Response

Patients in receive 10 mg of girentuximab coupled to DOTA and labeled with 65 mCi/m2 of Lu-177 if targeting of In-111-DOTA-girentuximab is observed in at least 1 lesion. Patients may be retreated no sooner than 12 weeks after the prior treatment with a dose of no more than 75% of the previous dose, for a total of not more than three treatments.

Drug: In-111-DOTA-girentuximab At day 1, every patient received girentuximab at a dose of 10 mg coupled to DOTA and labeled with 5 mCi of In-111.

Drug: Lu-177-DOTA-girentuximab At day 8-10, every patient receives girentuximab at a dose of 10 mg coupled to DOTA and labeled with 65 mCi/m2 of Lu-177. If eligible, patients are retreated at a dose 75% of the previous dose, for a total of not more than three treatments.

Lu-177-DOTA-girentuximab

W. J. Oyen, MD, PhD

P. F. Mulders, MD, PhD

To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with advanced clear cell renal cell carcinoma using RECIST criteria.

This is a Phase II study using Lu-177-DOTA-girentuximab for treatment of patients with advanced clear cell renal cell carcinoma. The trial requires 14 patients. CT scans will be carried out at baseline and after 12 weeks, for response assessment using RECIST criteria.

Patients will initially receive 5 mCi/10 mg Indium-111-DOTA-girentuximab antibody (an imaging dose preceeding Lu-177-girentuximab treatment). Whole body and blood measurements of radioactivity will be obtained on at least three occasions for one week to determine targeting and dosimetry. Only if at least one known and evaluable metastatic lesion is visualized with In-111-DOTA-girentuximab, therapeutic Lu-177-DOTA- girentuximab will be administered the following week. In the absence of disease progression and after recovery from toxicity, patients may be retreated no sooner than 12 weeks after the prior treatment with a dose of no more than 75% of the previous dose, for a total of not more than three treatments. Only patients who have normal pharmacokinetics on the preceding diagnostic In-111-girentuximab study (indicative of human antichimeric antibodies (HACA) negativity) are eligible for retreatment.

Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer

Phase II Study Of Lutetium-177 Labeled Chimeric Monoclonal Antibody Girentuximab (177Lu-DOTA-girentuximab) in Patients With Advanced Renal Cell Cancer

Progression free survival is defined as the time measured from the day of first administration of Lu-177-girentuximab to first progression or death, whichever comes first.

Toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v3.0)

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

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.

124-Iodine-cG250 (124I-cG250)

Chaitanya R Divgi, MD

Pual Russo, MD

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.

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.

Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.

Pilot Study of Iodine-124 Labeled Chimeric G250 (124I-cG250) in Presurgical Patients With Renal Masses

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.

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.

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.

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.

Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses 8 days after infusion.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

Age, Categorical

All patients who enrolled in the study and received 124-Iodine-cG250 (124I-cG250).

Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.

All patients who enrolled in the study, received 124I-cG250, had evaluable PET scans, had tissue samples analyzed and were PET-positive. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Fifteen patients were PET-positive.

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.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and were PET-negative. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Ten patients were PET-negative.

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.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and had a pathological diagnosis of clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Sixteen patients had clear cell renal cell carcinoma.

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.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and did not have clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Nine patients did not have clear cell RCC.

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 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 prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250	NCT00199875	Renal Cell Carc... Kidney Neoplasm Renal Cancer Kidney Cancer	Yttrium-90 conj...	18 Years -	Ludwig Institute for Cancer Research
Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer	NCT00142415	Metastatic Rena...	111-In-DOTA-cG2... 177-Lu-DOTA-cG2...	18 Years -	Ludwig Institute for Cancer Research
Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer	NCT00142415	Metastatic Rena...	111-In-DOTA-cG2... 177-Lu-DOTA-cG2...	18 Years -	Ludwig Institute for Cancer Research
Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250	NCT00199875	Renal Cell Carc... Kidney Neoplasm Renal Cancer Kidney Cancer	Yttrium-90 conj...	18 Years -	Ludwig Institute for Cancer Research
Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer	NCT02002312	Metastatic Clea...	Lu-177-DOTA-gir...	18 Years -	Radboud University Medical Center
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.	NCT00199888	Cancer of Kidne... Kidney Cancer Renal Cancer Neoplasms, Kidn... Renal Neoplasms Renal Cell Carc... Clear Cell Rena...	124-Iodine-cG25...	18 Years -	Ludwig Institute for Cancer Research

Spots Global Cancer Trial Database for cg250

Every month we try and update this database with for cg250 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cg250

Every month we try and update this database with for cg250 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cg250 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.