Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors

Inclusion Criteria: Histologically confirmed HER2/neu-overexpressing (2+ or 3+) malignancy by any standardized assay (fluorescence in-situ hybridization allowed) Measurable or evaluable disease Failed standard curative therapy No brain or CNS metastasis Hormone receptor status: Not specified Male or female Performance status - Karnofsky 70-100% At least 6 months Absolute neutrophil count at least 1,500/mm^3 Hemoglobin at least 8 g/dL (transfusion or epoetin alfa allowed) Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3.0 times ULN Hepatitis B surface antigen negative Creatinine no greater than 1.5 times ULN Calcium no greater than 11 mg/dL (calcium-lowering agents allowed) No active or unstable cardiovascular disease No cardiac disease requiring drug or device intervention No coronary artery disease No congestive heart failure Cardiac ejection fraction normal by echocardiogram or MUGA scan No significant peripheral neuropathy No significant CNS disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious concurrent infection requiring IV antibiotic therapy No clinically significant autoimmune disease (e.g., rheumatoid arthritis) No clinically significant gastrointestinal bleeding No uncontrolled peptic ulcer disease No inflammatory bowel disease No other major illness that would preclude study participation No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix No prior interleukin-12 No prior trastuzumab (Herceptin®) At least 3 weeks since prior chemotherapy At least 3 weeks since prior hormonal therapy No concurrent systemic corticosteroids At least 3 weeks since prior radiotherapy At least 3 weeks since prior surgery At least 3 weeks since prior investigational drug