CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250)biological
Likely dose
Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250) 1.0 mgfrom record
Key inclusion· 8
  • Histologically proven renal cell carcinoma with clinical presentation consistent with metastatic disease
  • Bidimensionally measurable disease by conventional imaging
  • Off chemotherapy or immunotherapy for at least 6 weeks prior to study entry
  • Karnofsky Performance Status at least 70
Key exclusion· 6
  • Significant prior radiation therapy to the entire pelvis and/or lumbosacral spine
  • Clinically significant cardiac disease
  • Serious infection requiring antibiotic treatment or other serious illness
  • Central Nervous System (CNS) tumor involvement

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

Search/NCT00003102
NCT00003102Phase 2Completed

Phase I/II Study of 131I-Labeled Chimeric Antibody G250 (131I-cG250) in Patients With Advanced Renal Carcinoma

Ludwig Institute for Cancer Research·interventional·Posted Aug 12, 2004·Updated Oct 4, 2023

In Brief

A Phase 2 clinical trial evaluating Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250) for Kidney Cancer. Completed, enrolled 15 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients with advanced kidney cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2004
Enrollment StartNov 17, 1998
Primary CompletionApr 19, 2000
Study CompletionMay 27, 2003
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 21.9 years ago

Interventions

Iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250)biological

cG250 is an IgG1 chimeric monoclonal antibody. It was supplied as a sterile solution at a concentration of 1.0 mg/mL in either a 2 mL or a 5 mL vial. cG250 was radiolabeled with Iodine-131 prior to use.