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

NCT00199875 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-10-10

Study results available
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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.

Conditions

Interventions

DRUG

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

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

Sponsors & Collaborators

Principal Investigators

  • Steven Larson, MD · Memorial Sloan Kettering Cancer Center

  • Neeta Pandit-Taskar, MD · Memorial Sloan Kettering Cancer Center

  • Joseph O'Donoghue, PhD · Memorial Sloan Kettering Cancer Center

  • Robert Motzer, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-06
Primary Completion
2013-03-14
Completion
2013-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00199875 on ClinicalTrials.gov