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

NCT00645060 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-02-27

No results posted yet for this study

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.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Y. Wong, MD · City of Hope Comprehensive Cancer Center

  • Stephen I. Shibata, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-09
Primary Completion
2016-09-06
Completion
2016-09-06

Countries

  • United States

Study Locations

More Related Trials

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 NCT00645060 on ClinicalTrials.gov