Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00645060
Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing high performance liquid chromatography, pharmacological study and radionuclide imaging in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- high performance liquid chromatography, pharmacological study and radionuclide imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2006to 6 Sep 2016
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced solid tumor for which no standard or effective treatment is available
- Patients who refuse an available standard but non-curative treatment may also be eligible
- Tumors must produce CEA as documented by either an elevated serum CEA above the upper limit of normal (ULN) or by immunohistochemical (IHC) methods
- Positive CEA IHC stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater
- Measurable disease
- Estimated < 1/3 of liver involvement if tumor involves the liver
- No brain or leptomeningeal involvement with cancer
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 3 months
- WBC ≥ 4,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 125,000/μL
- Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 mL/min
- Bilirubin ≤ 1.5 mg/dL
- ALT and AST ≤ 2 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception
- Patients currently being treated for severe infections or recovering from other intercurrent illnesses (such as poorly controlled diabetes or hypertension) are ineligible until recovery is deemed complete by the investigator
- Serum anti-antibody testing must be negative for human anti-humanized antibodies (if patient received prior monoclonal antibody)
- Serum HIV-negative
- Serum hepatitis B antigen- and hepatitis C antibody-negative
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior radiotherapy, immunotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
- Recovered from prior major surgery
- No prior radiotherapy to > 50% of bone marrow
- No other concurrent chemotherapy, radiotherapy, or immunotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies
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.
Read the 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.
- Being tested
- high performance liquid chromatography, pharmacological study, radionuclide imaging, single photon emission computed tomography, yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high performance liquid chromatographyOther
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
radionuclide imagingProcedure or surgery
1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post Y-90 anti-CEA antibody infusion
single photon emission computed tomographyProcedure or surgery
2 days and 3-5 days post antibody infusion
yttrium Y 90 DOTA anti-CEA monoclonal antibody M5ARadiation
Dose escalation from 12 mCi/m2 through 18 mCi/m2 increasing by 2 mCi/m2 with each escalation
| Study group | Role | What they receive |
|---|---|---|
| Y-90-DOTA-M5A anti-CEA antibody | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 10 weeks after the beginning of the last cycle of treatment
Toxicity
Measured: 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
Measured: From 3 months after treatment completion or until death
Progression-free survival
Measured: From 3 months after treatment completion until cancer progression or start of another treatment
Time to progression
Measured: 3 months and six months after treatment completion until cancer progression or start of another treatment
Pharmacokinetic and molecular studies
Measured: At 0, 1, 4-6, 12-24, 48, 72-120 and 144-168 hours after administration of the baseline imaging dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study start28 Nov 2006
- Primary completion6 Sep 2016
- Study completion6 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Y. Wong, MD, Principal investigator, City of Hope Medical CenterStephen I. Shibata, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645060
- Sponsor's protocol ID
- 05198
- Other IDs
- P30CA033572, CHNMC-05198, CDR0000590300
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2008
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes