Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye

This is an interventional treatment trial for Ciliary Body and Choroid Melanoma, Medium/Large Size Read More

Inclusion Criteria:

• Patients must have a history of uveal melanoma and documented metastatic disease
• Patients must have at least one unidimensionally measurable lesion; if this is a cutaneous lesion it must be at least 10 mm by caliper measure; if it is a visceral or nodal or soft tissue lesion, it must be clearly measurable > 20 mm with conventional techniques or > 10 mm with spiral CT scan; bone lesions are not considered measurable

• One prior systemic chemotherapy and any number of immunotherapies or vaccine therapies are allowed; prior treatment with hepatic arterial chemotherapy infusion or perfusion or chemoembolization of liver metastasis is allowed; prior treatment with radiation therapy is allowed but not more than 3000 cGy to fields including substantial marrow; patients are not required to have had prior therapy

  • At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy; if progression occurred during therapy, patient must have recovered from any side effects
  • At least 4 weeks (28 days) since prior radiotherapy and prior adjuvant chemotherapy
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Patients must have a life expectancy of at least 3 months
• Leukocytes > 3,000/mm3
• Absolute neutrophil count ≥ 1,500/mm3
• Hemoglobin ≥ 9.0 g/dL
• Platelets ≥ 100,000/mm3
• Aspartate transaminase-alanine transaminase ratio (AST(SGOT)/ALT(SGPT)) ≤ 3 times institutional upper limit of normal (ULN); ≤ 5 times institutional ULN if liver metastases present
• Total bilirubin < 1.5 times institutional ULN
• Creatinine < 1.5 times institutional ULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Fasting serum glucose < 120 mg/dL or < institutional ULN
• Patients must have no angina at rest
• The effects of IMC-A12 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because monoclonal antibodies could be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation 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
• Both men and women and members of all races and ethnic groups are eligible for this trial
• Patients must have the ability to understand and the willingness to sign a written informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution

Exclusion Criteria:

• Patients whose site of primary melanoma is not uveal
• Patients who have a current history of neoplasm other than the entry diagnosis except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years
• Patients with symptomatic central nervous system metastasis including those with central nervous system (CNS) metastasis who require oral steroids for cerebral edema or have progression on CT/MRI
• Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control; patients may not breast-feed while on this study; pregnant women are excluded from this study because IMC-A12 is a monoclonal antibody with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IMC-A12, breastfeeding women are excluded
• Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals)
• Patients with poorly controlled diabetes mellitus; patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below institutional ULN) and that they are on a stable dietary or therapeutic regimen for this condition
• Patients with unstable or serious concurrent medical conditions are excluded; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
• Patients with one or more of the following as the only manifestations of disease are ineligible: leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis
• Patients with Gilbert's Syndrome
• Patients must not have had major surgery within the past 14 days
• Patients must not receive any concurrent chemotherapy or immunotherapy while on study; only palliative radiotherapy is permitted to symptomatic lesions in which event the irradiated lesions may not be considered target or non-target lesions for response; palliative radiation immediately before or during the study is acceptable provided there is evaluable disease that has been radiated; palliative radiation is acceptable provided that the irradiated lesions are not used to determine response assessment
• HIV-positive patients with an absolute CD4 count < 300 K/uL
• Patients may not be receiving any other investigational agents
• Patients with a history of treatment with other agents targeting the insulin-like growth factor pathway
• Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12