Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): high performance liquid chromatography; pharmacological study; radionuclide imaging; single photon emission computed tomography; yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Intervention type(s): Other; Other; Procedure; Procedure; Radiation
Intervention description(s): Performed on serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples; Serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples; 1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post Y-90 anti-CEA antibody infusion; 2 days and 3-5 days post antibody infusion; Dose escalation from 12 mCi/m2 through 18 mCi/m2 increasing by 2 mCi/m2 with each escalation
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific