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COMPLETED
NCT00645060
PHASE1

Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for advanced cancer. PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A in treating patients with advanced solid tumors.

Official title: A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2006-11-28

Completion Date

2016-09-06

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

OTHER

high performance liquid chromatography

Performed on serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples

OTHER

pharmacological study

Serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples

PROCEDURE

radionuclide imaging

1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post Y-90 anti-CEA antibody infusion

PROCEDURE

single photon emission computed tomography

2 days and 3-5 days post antibody infusion

RADIATION

yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A

Dose escalation from 12 mCi/m2 through 18 mCi/m2 increasing by 2 mCi/m2 with each escalation

Locations (1)

City of Hope Comprehensive Cancer Center

Duarte, California, United States