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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-05198 | |||
| CDR0000590300 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A (MOAB M5A).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Y-90-DOTA-M5A anti-CEA antibody | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high performance liquid chromatography | Other | Performed on serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor for which no standard or effective treatment is available
Tumors must produce CEA as documented by either an elevated serum CEA above the upper limit of normal (ULN) or by immunohistochemical (IHC) methods
Measurable disease
Estimated < 1/3 of liver involvement if tumor involves the liver
No brain or leptomeningeal involvement with cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Y. Wong, MD | City of Hope Medical Center | Principal Investigator |
| Stephen I. Shibata, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| pharmacological study | Other | Serial blood samples from 0 to 168 hours and daily X5 days 24 hour urine samples |
|
| radionuclide imaging | Procedure | 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 tomography | Procedure | 2 days and 3-5 days post antibody infusion |
|
| yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A | Radiation | Dose escalation from 12 mCi/m2 through 18 mCi/m2 increasing by 2 mCi/m2 with each escalation |
|
| ID | Term |
|---|---|
| D002851 | Chromatography, High Pressure Liquid |
| ID | Term |
|---|---|
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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