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Treatment of Patients With Advanced Renal Cancer With a Radio-labeled 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 : Unknown
Verified May 2011 by Ludwig Institute for Cancer Research.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : May 10, 2011
Memorial Sloan Kettering Cancer Center
Information provided by:
Ludwig Institute for Cancer Research

Brief Summary:
This is a phase 1 study that will only be carried out at Memorial Sloan-Kettering Cancer Center. Patients will receive a radiolabeled antibody, called Yttrium-90 chimeric G250 (90Y-cG250).The goal of a phase 1 trial is to establish a safe dose range based on side effects;in other studies, these side effects have been reversible and lasted a short time (hours to days). If possible, the trial will also give us an idea of how well the drug might work in treating your disease.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Kidney Neoplasm Renal Cancer Kidney Cancer Drug: Yttrium-90 conjugated chimeric G250 (90Y-cG250) Phase 1

Detailed Description:

This is a Phase I dose escalation study using 90Y-DOTA-cG250 for treatment of patients with advanced kidney carcinoma. The initial group of patients will be treated with 0.2 mCi/Kg of yttrium-90. Subsequent treatments will be in 0.1 mCi/Kg increments, with the last cohort increasing by 0.05 mCi/Kg. At least three patients per dose level will be followed for up to 8 weeks (or after recovery from toxicity) with imaging, biochemical, serological, and hematologic tests for toxicity. CT scans will be carried out at baseline and after 6-8 weeks (or after recovery from toxicity).

Patients will initially receive 5 mCi/10 mg 111In-DOTA-cG250 antibody (an imaging dose). Whole body and blood measurements of radioactivity will be obtained on at least three occasions for one week to determine targeting and dosimetry. Therapeutic 90Y-DOTA-cG250 will be administered the following week, if there is evidence of In-111 cG250 targeting to lesions > 2 cm detected on CT. Patients will be treated as outpatients and will receive only one treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (90Y-DOTA-cG250) in Patients With Advanced Renal Cancer
Study Start Date : July 2005
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
Drug Information available for: Yttrium
U.S. FDA Resources

Primary Outcome Measures :
  1. Toxicity defined by NCI Common Toxicity Criteria

Secondary Outcome Measures :
  1. Assessment of selective uptake of 111In-cG250 in tumor with favorable biodistribution
  2. Radiation absorbed dose to blood and whole body of 90Y-cG250 as determined by measurement of 111-In in serum and whole body
  3. HACA - measured by ELISA

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must have histologically proven clear cell renal carcinoma.
  • All patients must have a clinical presentation consistent with metastatic renal carcinoma.
  • Patients must have bidimensionally measurable disease by conventional imaging methods including radiography, ultrasound, computer tomography, or other anatomic imaging modalities.
  • Female patients of childbearing age are required to have a negative pregnancy test carried out the day of and prior to receiving therapy
  • All patients must be ambulatory with a Karnofsky Performance Status of at least 70

Exclusion Criteria:

  • Significant prior radiotherapy to the entire pelvis and/or lumbosacral spine.
  • Clinically significant cardiac disease
  • Serious infection or other serious illness.
  • Evidence of CNS tumor involvement.
  • Patients known to have hepatobiliary disease and/or HIV/AIDS.
  • Pregnancy or breastfeeding.
  • Refusal or inability to use effective means of contraception in men or women of childbearing potential.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199875

Contact: Christina E Hong 212-639-7246 hongc@mskcc.org

United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Steve Larson, MD    212-693-7373      
Contact: Motzer         
Principal Investigator: Steve Larson, MD         
Principal Investigator: Joseph O'Donoghue, PhD         
Principal Investigator: Neeta Pandit-Taskar, M D         
Principal Investigator: Robert Mozter, MD         
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Memorial Sloan Kettering Cancer Center
Principal Investigator: Robert Motzer, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Joseph O'Donoghue, PhD Memorial Sloan Kettering Cancer Center
Principal Investigator: Steve Larson, MD Memorial Sloan Kettering Cancer Center

Responsible Party: Ralph Venhaus, MD, Head of Clinical and Regulatory Affairs, Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00199875     History of Changes
Other Study ID Numbers: LUD2002-022
MSKCC IRB #: 05-031
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: May 2011

Keywords provided by Ludwig Institute for Cancer Research:
renal cell carcinoma
advanced renal cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs