NCT01413191

Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye

Phase II Study of IMC-A12 in Metastatic Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the response rate of metastatic uveal melanoma when treated with IMC-A12 (cixutumumab). II. To determine the safety and tolerability of IMC-A12 in patients with metastatic uveal melanoma. SECONDARY OBJECTIVES: I. To determine the disease control rate of patients treated with IMC-A12. II. To determine the duration of response of patients treated with IMC-A12. III. To determine the progression-free survival and overall survival of patients treated with IMC-A12. TERTIARY OBJECTIVES: I. To correlate the presence of GNAQ and GNA11 mutations with response to IMC-A12. II. To correlate the expression of IGF-1R with response to IMC-A12. III. To determine the effect of IMC-A12 on expression of proteins involved in initiation, growth, and spread of uveal melanoma cells. IV. To determine resistance mechanisms to IMC-A12. OUTLINE: This is a multicenter study. Patients receive cixutumumab intravenously (IV) over 1 hour on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Archived and fresh tumor tissue and serum samples may be collected for correlative studies. After completion of study treatment, patients are followed up for 30 days and then every 3 months for 1 year.

Conditions

• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Ciliary Body and Choroid Melanoma, Small Size
• Iris Melanoma
• Metastatic Intraocular Melanoma
• Recurrent Intraocular Melanoma
• Stage IV Intraocular Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Cixutumumab	10 mg/kg IV infusion over 1 hour every 2 weeks with treatment cycle defined as 4 weeks
OTHER	Laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-03-01
• Completion: 2014-06-01
• First posted: 2011-08-10
• Last updated: 2020-02-19
• Results posted: 2015-07-20

Locations

2 sites across 1 country: United States