| Inclusion Criteria: | 1) Patients must have a history of uveal melanoma and documented metastatic disease.
2) 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.
3) 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.
4) 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.
5) At least 4 weeks (28 days) since prior radiotherapy and prior adjuvant chemotherapy.
6) Patients must have ECOG performance status of 0 - 2.
7) Patients must be >/= 17 years of age or older. Because no dosing or adverse event data are currently available on the use IMC-A12 in patients <17 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
8) Patients must have a life expectancy of at least 3 months.
9) Patients must have normal organ and marrow function as: leukocytes > 3,000/mm3, absolute neutrophil count >= 1,500/mm3, hemoglobin >= 9.0 g/dL, platelets >= 100,000/mm3, AST(SGOT)/ALT(SGPT) <= 3 X institutional upper limit of normal (ULN); <= 5 X institutional ULN if liver metastases present, total bilirubin < 1.5 X institutional ULN, creatinine < 1.5 X 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.
10) Patients must have no angina at rest.
11) 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.
12) Both men and women and members of all races and ethnic groups are eligible for this trial.
13) 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.
14) Patients must have 15-20 slides of metastatic tissue for enrollment. This may take the form of archived tissue or fresh tissue biopsy. |