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 chromatographyOther: pharmacological studyProcedure: radionuclide imagingProcedure: single photon emission computed tomographyRadiation: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
- Registration Number
- NCT00645060
- Lead Sponsor
- City of Hope Medical Center
- Brief 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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Y-90-DOTA-M5A anti-CEA antibody pharmacological study - Y-90-DOTA-M5A anti-CEA antibody high performance liquid chromatography - Y-90-DOTA-M5A anti-CEA antibody radionuclide imaging - Y-90-DOTA-M5A anti-CEA antibody single photon emission computed tomography - Y-90-DOTA-M5A anti-CEA antibody yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A -
- Primary Outcome Measures
Name Time Method Overall survival From 3 months after treatment completion or until death Progression-free survival From 3 months after treatment completion until cancer progression or start of another treatment Time to progression 3 months and six months after treatment completion until cancer progression or start of another treatment Pharmacokinetic and molecular studies At 0, 1, 4-6, 12-24, 48, 72-120 and 144-168 hours after administration of the baseline imaging dose Maximum tolerated dose 10 weeks after the beginning of the last cycle of treatment Toxicity 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States