Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed solid tumor
• •* Inoperable or metastatic disease
• •Failed standard therapy
• •Confirmed cancer antigen (CanAg) expression
• •* Patients must have non-colorectal cancer or pancreatic cancer
• •* Tumor must have a homogeneous pattern (i.e., staining present in \> 75% of tumor cells for CanAg) and are 2+ or 3+ intensity by immunohistochemistry \* No known leptomeningeal disease or progressive brain disease
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy ≥ 12 weeks
• •Absolute neutrophil count ≥ 1,500/mm³
• •Hemoglobin ≥ 9 g/dL (transfusion allowed)
• •Platelet count ≥ 100,000/mm³
• •aPTT and INR ≤ 1.5 times upper limit of normal (ULN)
• •Creatinine ≤ 1.5 mg/dL
• •Creatinine clearance ≥ 60 mL/min
• •Bilirubin ≤ 1.5 mg/dL
• •AST and ALT \< 2.5 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 30 days after completion of study treatment
• •No hypersensitivity to agents of the same class as the study drug, humanized or nonhumanized antibodies, or immunoconjugates
• •No active, uncontrolled infection
• •No hepatitis B surface antigen or hepatitis C antibody positivity
• •No history of alcoholic liver disease
• •No serious medical or psychiatric disorder that would preclude compliance with study requirements
• •No peripheral neuropathy \> grade 1
• •No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer
• •No severe concurrent disease or condition that, in the opinion of the investigator, would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Recovered from prior therapy
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C)
• •At least 4 weeks since prior radiotherapy, immunotherapy, or hormone therapy for cancer
• •At least 4 weeks since prior major surgery
• •No concurrent chemotherapy, other immunotherapy, radiotherapy, or other investigational therapy
• •* Palliative radiotherapy for related bone metastases allowed
• •No other concurrent anticancer therapy