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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Ludwig Institute for Cancer Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00199875
First received: September 13, 2005
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • Toxicity defined by NCI Common Toxicity Criteria

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

Estimated Enrollment: 24
Study Start Date: July 2005
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199875

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

Locations
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
Investigators
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
  More Information

No publications provided

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
Study First Received: September 13, 2005
Last Updated: May 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
antibody
renal cell carcinoma
advanced renal cancer
cG250
90Y

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

ClinicalTrials.gov processed this record on October 21, 2014