Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

Inclusion Criteria

• •1. Subjects must have histologically confirmed pleural or peritoneal mesothelioma not amenable to potentially curative surgical resection. The diagnosis will be confirmed by the pathology department / Center for Cancer Research (CCR) / National Cancer Institute (NCI).
• •2. Patients must have had at least one prior platinum-containing chemotherapy regimen. There is no limit to the number of prior chemotherapy regimens received.
• •3. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral computed tomography (CT) scan.
• •4. Patients must not have had major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study and must have evidence of stable or progressive disease to be eligible.
• •5. Age greater than or equal to 18 years. Since mesothelioma is extremely rare in children they are excluded from this study.
• •6. Life expectancy of greater than 3 months.
• •7. Performance status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2.
• •8. Patients must have adequate organ and marrow function (as defined below).
• •* leukocytes greater than or equal to 3,000/mm\^3
• •* absolute neutrophil count greater than or equal to 1,500/mm\^3
• •* hemoglobin greater than or equal to 9 g/dL
• •* platelets greater than or equal to 100,000/ mm\^3
• •* total bilirubin less than or equal to 1.5 times institutional upper limit of normal (ULN)
• •* Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase(SGPT) less than or equal to 3 times institutional ULN
• •(5 times if liver function test (LFT) elevations due to liver metastases)
• •* creatinine less than or equal to 1.5 times institutional ULN
• •OR
• •\- creatinine clearance greater than or equal to 60 mL/min/1.73 m\^2 for patients with creatinine
• •levels above institutional normal
• •Patients may be transfused to obtain a hemoglobin of greater than or equal to 9 g/Dl.
• •9. The patient must have fasting serum glucose \< 160 mg/dL
• •10. The effects of IMC-A12 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of IMC-A12. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. While hormonal methods of birth control are effective, we ask that female patients who are participating in the study cease hormonal forms of birth control, as these methods of birth control (birth control pills, injections, or implants) may affect the study drug. Patients must be off hormonal forms of birth control for at least 4 weeks prior to initiating the study.
• •11. Ability to comply with intravenous administration schedule, and the ability to understand and the willingness to sign a written informed consent document.
• •Inclusion of Women and Minorities
• •Both men and women and members of all races and ethnic groups are eligible for this trial. Every effort will be made to recruit women and minorities in this study.