TheranosticTrials.org

Clinical Trial · NCT00199875

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

Overview

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.

Sponsor

Olivia Newton-John Cancer Research Institute

Phase

Phase 1

Contacts

Neeta Pandit-Taskar, MD (PRINCIPAL_INVESTIGATOR)

Robert Motzer, MD (PRINCIPAL_INVESTIGATOR)

Joseph O'Donoghue, PhD (PRINCIPAL_INVESTIGATOR)

Steven Larson, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00199875

Drug / Compound

cG250

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DOTA

cG250

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

  • Patients must have had bidimensionally measurable disease by conventional imaging methods including radiography, ultrasound, CT, or other anatomic imaging modalities. Lesions seen on skeletal scintigraphy alone were not considered measurable.
  • All patients must have been ambulatory with a Karnofsky Performance Status of at least 70.
  • All patients must have had a clinical presentation consistent with metastatic renal carcinoma.

Exclusion

  • Patients with central nervous system (CNS) involvement were excluded under the following criteria:
  • Evidence of progression of neurologic CNS involvement within 3 months prior to entering the protocol.
  • Patients known to have hepatobiliary disease and/or human immunodeficiency virus/acquired immune deficiency syndrome.
  • Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to study agent administration.
  • Significant prior radiotherapy (\> 30 Gy) to the entire pelvis and/or lumbosacral spine.
  • Brain metastasis, except for stable disease over 3 months.
  • Untreated brain metastasis.