Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Anti-Lewis Y Immunotoxin Admistered by Continuous Infusion

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced colon, breast, non-small cell
lung, bladder, pancreas, or ovarian cancer refractory to standard treatment or for
which no effective standard therapy exists

- Expresses Lewis Y antigen

- Evidence of disease progression

- B3 antigen on the surface of more than 30% of the tumor cells determined by
immunohistochemistry

- No neutralizing antibodies to LMB-9 immunotoxin

- No untreated CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Male or female

Performance status:

- ECOG 0-1

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute granulocyte count greater than 1,200/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT and SGPT no greater than 2.5 times upper limit of normal (liver metastases
allowed)

- Albumin at least 3.0 g/dL

- No prior liver disease (e.g., alcohol liver disease)

- Hepatitis B and C negative

Renal:

- Creatinine no greater than 1.4 mg/dL

- Creatinine clearance greater than 60 mL/min

- Proteinuria less than 1 g/24 hours

Cardiovascular:

- No history of coronary artery disease

- No cardiac arrhythmia requiring therapy

- No New York Heart Association class II-IV congestive heart failure

Pulmonary:

- Pulmonary function test required if significant smoking history, possible pulmonary
disease, or lung cancer

- FEV1 and FVC at least 65% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known seizure disorders

- No urinary tract infection

- No other concurrent malignancy

- No active peptic ulcer disease

- No known allergy to omeprazole

- No contraindication to pressor therapy

- No other concurrent medical or psychological condition that would preclude study

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and
recovered

Endocrine therapy:

- At least 3 weeks since prior hormonal therapy

Radiotherapy:

- At least 3 weeks since prior radiotherapy and recovered