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

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00645060

Purpose

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	Intervention	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 I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nuclear Scans

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]
Pharmacokinetic and molecular studies [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2006
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645060

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Preeyarat Kloythanomsup 800-826-4673

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Jeffrey Y. Wong, MD	Beckman Research Institute
Principal Investigator:	Stephen I. Shibata, MD	Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000590300, CHNMC-05198
Study First Received:	March 26, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00645060 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Immunologic Factors
Immunoglobulins

Additional relevant MeSH terms:

Antibodies, Monoclonal
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009