Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye (NCT01413191) | Clinical Trial Compass
CompletedPhase 2
Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye
United States18 participantsStarted 2011-08
Plain-language summary
This phase II trial studies how well giving cixutumumab works in treating patients with metastatic melanoma of the eye. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
Who can participate
Age range17 Years
SexALL
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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…