A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies

Inclusion 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