Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 44 for:    CA-9

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00199875
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Renal Cell Carcinoma
Kidney Neoplasm
Renal Cancer
Kidney Cancer
Intervention Drug: Yttrium-90 conjugated chimeric G250 (^90Y-DOTA-cG250)
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 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)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 3 3 6 3 3
Completed 3 3 6 3 2
Not Completed 0 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1
Arm/Group Title 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
Hide Arm/Group Description 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. Total of all reporting groups
Overall Number of Baseline Participants 3 3 6 3 3 18
Hide Baseline Analysis Population Description
The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants 3 participants 3 participants 18 participants
65.7  (9.2) 64.7  (4.9) 62.7  (7.9) 63.7  (6.8) 63.0  (5.9) 63.7  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 3 participants 3 participants 18 participants
Female
1
  33.3%
1
  33.3%
3
  50.0%
0
   0.0%
2
  66.7%
7
  38.9%
Male
2
  66.7%
2
  66.7%
3
  50.0%
3
 100.0%
1
  33.3%
11
  61.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 3 participants 3 participants 18 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
18
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 3 participants 3 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
1
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
   5.6%
White
3
 100.0%
3
 100.0%
6
 100.0%
2
  66.7%
2
  66.7%
16
  88.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants 3 participants 3 participants 18 participants
3
 100.0%
3
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
18
 100.0%
Karnofsky Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 3 participants 3 participants 18 participants
70
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
   5.6%
80
1
  33.3%
0
   0.0%
1
  16.7%
0
   0.0%
3
 100.0%
5
  27.8%
90
2
  66.7%
2
  66.7%
3
  50.0%
2
  66.7%
0
   0.0%
9
  50.0%
100
0
   0.0%
0
   0.0%
1
  16.7%
1
  33.3%
0
   0.0%
2
  11.1%
Missing
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
[1]
Measure Description:

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.

1.Primary Outcome
Title Number of Patients With Treatment-emergent Adverse Events
Hide Description 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.
Time Frame Continuously for up to 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3 3 6 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
3
 100.0%
3
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
Maximum grade 1 TEAE
2
  66.7%
2
  66.7%
2
  33.3%
1
  33.3%
0
   0.0%
Maximum grade 2 TEAE
0
   0.0%
1
  33.3%
1
  16.7%
0
   0.0%
0
   0.0%
Maximum grade 3 TEAE
1
  33.3%
0
   0.0%
3
  50.0%
1
  33.3%
1
  33.3%
Maximum grade 4 TEAE
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
2
  66.7%
Treatment-related TEAE
2
  66.7%
3
 100.0%
5
  83.3%
3
 100.0%
3
 100.0%
Serious TEAE
0
   0.0%
0
   0.0%
1
  16.7%
1
  33.3%
0
   0.0%
TEAE Leading to Treatment Discontinuation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
TEAE Meeting DLT Criteria
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
2
  66.7%
2.Secondary Outcome
Title Number of Patients Who Met Protocol-Specified Criteria to Receive ^90-Y-DOTA-cG250 Following ^111In-DOTA-cG250 Administration
Hide Description 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.
Time Frame Up to 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3 3 6 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
3
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
3.Secondary Outcome
Title Number of Patients With Samples Collected for Evaluation of Human Antichimeric Antibody
Hide Description 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.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.
Arm/Group Title 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)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3 3 6 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
3
 100.0%
3
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
Day 28
3
 100.0%
3
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
Day 42
3
 100.0%
3
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
Day 63
3
 100.0%
3
 100.0%
6
 100.0%
2
  66.7%
2
  66.7%
Long-term Follow-up
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
Time Frame All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 5 months.
Adverse Event Reporting Description 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.
 
Arm/Group Title 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)
Hide Arm/Group Description 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.
All-Cause Mortality
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/3 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   1/6 (16.67%)   1/3 (33.33%)   0/3 (0.00%) 
Metabolism and nutrition disorders           
Hypercalcaemia  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal chest pain  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Respiratory tract haemorrhage  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   6/6 (100.00%)   3/3 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders           
Lymphopenia  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  2/3 (66.67%)  3/3 (100.00%) 
Gastrointestinal disorders           
Nausea  1  0/3 (0.00%)  2/3 (66.67%)  1/6 (16.67%)  0/3 (0.00%)  2/3 (66.67%) 
Diarrhoea  1  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Constipation  1  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Abdominal distension  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Abdominal pain upper  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Vomiting  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Abdominal pain  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  2/3 (66.67%) 
General disorders           
Fatigue  1  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  1/3 (33.33%)  3/3 (100.00%) 
Mucosal inflammation  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Pyrexia  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Chills  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Oedema peripheral  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Chest pain  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hepatobiliary disorders           
Hyperbilirubinaemia  1  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Immune system disorders           
Hypersensitivity  1  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Infections and infestations           
Urinary tract infection  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Investigations           
Blood alkaline phosphatase  1  2/3 (66.67%)  0/3 (0.00%)  3/6 (50.00%)  1/3 (33.33%)  1/3 (33.33%) 
Haemoglobin  1  2/3 (66.67%)  0/3 (0.00%)  5/6 (83.33%)  3/3 (100.00%)  3/3 (100.00%) 
International normalised ratio  1  2/3 (66.67%)  0/3 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  1/3 (33.33%) 
Platelet count  1  2/3 (66.67%)  3/3 (100.00%)  5/6 (83.33%)  3/3 (100.00%)  3/3 (100.00%) 
Alanine aminotransferase  1  1/3 (33.33%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  2/3 (66.67%) 
Blood creatinine  1  1/3 (33.33%)  2/3 (66.67%)  5/6 (83.33%)  1/3 (33.33%)  1/3 (33.33%) 
Prothrombin time  1  1/3 (33.33%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
White blood cell count  1  1/3 (33.33%)  2/3 (66.67%)  3/6 (50.00%)  2/3 (66.67%)  3/3 (100.00%) 
Amylase  1  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Aspartate aminotransferase  1  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Blood bicarbonate decreased  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Neutrophil count  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  3/3 (100.00%) 
Metabolism and nutrition disorders           
Hypoalbuminaemia  1  2/3 (66.67%)  0/3 (0.00%)  3/6 (50.00%)  1/3 (33.33%)  3/3 (100.00%) 
Hyperglycaemia  1  1/3 (33.33%)  3/3 (100.00%)  6/6 (100.00%)  3/3 (100.00%)  3/3 (100.00%) 
Hyperkalaemia  1  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  1/3 (33.33%)  2/3 (66.67%) 
Hypernatraemia  1  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Decreased appetite  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypophosphataemia  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hyponatraemia  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  2/3 (66.67%) 
Hypoglycaemia  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Musculoskeletal chest pain  1  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Arthralgia  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Nervous system disorders           
Peripheral sensory neuropathy  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Dysarthria  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Psychiatric disorders           
Anxiety  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Hypoxia  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Increased upper airway secretion  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  2/3 (66.67%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Macri, Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
Phone: (212) 450-1546
EMail: mmacri@licr.org
Layout table for additonal information
Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00199875    
Other Study ID Numbers: LUD2002-022
MSKCC IRB #: 05-031 ( Other Identifier: MSKCC IRB )
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: April 17, 2018
Results First Posted: November 28, 2018
Last Update Posted: November 28, 2018