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