Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00645060|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2008
Last Update Posted : May 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Other: high performance liquid chromatography Other: pharmacological study Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A||Phase 1|
- To establish the maximum tolerated dose of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A and describe the toxicities at each dose studied.
- To estimate radiation doses to whole body, normal organs, and tumor through serial nuclear imaging studies after intravenous infusion of the yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A.
OUTLINE: This is a dose-escalation study of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A (MOAB M5A).
- Biodistribution: Patients receive indium In 111 radiolabeled anti-CEA MOAB M5A IV over 30 minutes. Patients undergo serial nuclear scans, single photon emission computed tomography (SPECT), and blood and urine sampling over 1 week to estimate absorbed radiation doses to tumor, normal organs (i.e., liver, lung, kidney, and bone marrow), and whole body.
- Treatment: No more than 2 weeks later, patients with adequate biodistribution receive yttrium Y 90 DOTA anti-CEA MOAB M5A IV over 30 minutes on day 1. Patients then undergo serial nuclear scans, SPECT, and blood and urine sampling over 1 week to estimate absorbed radiation doses to tumor, normal organs (i.e., liver, lung, kidney, and bone marrow), and whole body. Treatment repeats every 6-10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Blood and urine samples are collected periodically for analysis of total activity by radiometric high performance liquid chromatography and to acquire data on antibody metabolism and pharmacokinetics.
After completion of study treatment, patients are followed every 3 months for up to 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies|
|Study Start Date :||October 9, 2006|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
|Experimental: Y-90-DOTA-M5A anti-CEA antibody||
Other: high performance liquid chromatography
Performed on serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samplesOther: pharmacological study
Serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samplesProcedure: radionuclide imaging
1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post Y-90 anti-CEA antibody infusionProcedure: single photon emission computed tomography
2 days and 3-5 days post antibody infusionRadiation: 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
- Maximum tolerated dose [ Time Frame: 10 weeks after the beginning of the last cycle of treatment ]
- Toxicity [ Time Frame: From the date of the beginning of the first cycle of treatment to 10 weeks from the date of the beginning of the last cycle of treatment ]
- Overall survival [ Time Frame: From 3 months after treatment completion or until death ]
- Progression-free survival [ Time Frame: From 3 months after treatment completion until cancer progression or start of another treatment ]
- Time to progression [ Time Frame: 3 months and six months after treatment completion until cancer progression or start of another treatment ]
- Pharmacokinetic and molecular studies [ Time Frame: At 0, 1, 4-6, 12-24, 48, 72-120 and 144-168 hours after administration of the baseline imaging dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645060
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Jeffrey Y. Wong, MD||City of Hope Comprehensive Cancer Center|
|Principal Investigator:||Stephen I. Shibata, MD||City of Hope Comprehensive Cancer Center|