CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Yttrium-90 conjugated chimeric G250 (^90Y-DOTA-cG250)drug
Likely dose
Escalating doses of yttrium-90 conjugated chimeric G250 (90Y-DOTA-cG250) administered as single infusion; specific MTD doses not predeterminedAI-extracted
Key inclusion· 6
  • Histologically proven clear cell renal carcinoma
  • Metastatic disease with clinical presentation consistent with metastatic renal carcinoma
  • Bidimensionally measurable disease by conventional imaging (radiography, ultrasound, CT, or other anatomic imaging)
  • Age ≥18 years
Key exclusion· 8
  • Significant prior radiotherapy >30 Gy to entire pelvis and/or lumbosacral spine
  • Clinically significant cardiac disease (NYHA Class III/IV)
  • Serious infection requiring antibiotic treatment or other serious illness
  • Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to study agent administration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00199875
NCT00199875Phase 1Completed

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

Ludwig Institute for Cancer Research·interventional·Posted Sep 20, 2005·Updated Oct 10, 2022

In Brief

A Phase 1 clinical trial evaluating Yttrium-90 conjugated chimeric G250 (^90Y-DOTA-cG250) for Renal Cell Carcinoma and 3 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJul 6, 2005
Primary CompletionMar 14, 2013
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 20.8 years ago

Interventions

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

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