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Completed
NCT00645060
Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: City of Hope Medical Center
Location: City of Hope Comprehensive Cancer Center Duarte California
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT00645060). StuddyBuddy aggregates publicly available trial information.