INCLUSION CRITERIA:
Histopathologic diagnosis of one of the following malignancies:
Ovarian carcinoma, all non-mucinous epithelial histologies, including primary peritoneal and fallopian tube carcinoma;
Malignant mesothelioma, except sarcomatous histology;
Pancreatic cancer positive for mesothelin;
Squamous cell cancer of the lung;
Squamous cell cancer of the cervix;
Squamous cell cancer of the head and neck.
Tissue block must be available for analysis. Tumor, initial or recurrent, must be positive (greater than or equal to 30% of tumor cells) for mesothelin by immunohistochemistry.
Recurrent unresectable disease after appropriate definitive therapy. Patients must have received prior therapy considered standard for their particular cancer, unless refused by the patient.
At least 4 weeks since any prior therapy, with recovery from side effects. No concurrent anti-tumor treatment of any kind.
Measurable or evaluable tumor documented within 4 weeks prior to study entry.
Age greater than or equal to 18 years.
Life expectancy greater than or equal to 12 weeks.
Performance Status (ECOG) 0-2.
Adequate organ function, including:
ANC greater than or equal to 1,500/mm(3); Plts greater than or equal to 75,000/mm(3);
Creatinine, Ca(2+) and total Bilirubin less than or equal to upper limit normal (ULN); AST (SGOT) and ALT (SGPT) less than or equal to 2.5 x ULN;
Albumin greater than or equal to 3.0 gm/dL;
Baseline O(2) saturation greater than or equal to 93% (room air);
Pulmonary function tests (PFT), including FEV(1), TLC, DL(CO), and VC, greater than or equal to 50% of predicted value (for those patients with pleural mesothelioma and as clinically indicated).
Informed consent, in accordance with institutional criteria, signed prior to any study specific procedures or assessments.
EXCLUSION CRITERIA:
Patient may not have any of the following:
Any known CNS or spinal cord involvement by tumor.
Serum neutralizing activity to SSI (dsFv)-PE38 at 200 ng/mL is greater than 75%.
Concurrent antitumor therapy.
Cardiovascular condition NY Heart Association Grade II-IV, or clinically-significant pericardial effusion.
Any infection requiring parenteral antibiotics, history of HIV infection, or seropositivity for Hepatitis B and Hepatitis C.
Be pregnant or nursing. Females of child-bearing potential must use an effective method of contraception.
Warren Grant Magnuson Clinical Center (CC)