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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
10 mg/kg IV infusion over 1 hour every 2 weeks with treatment cycle defined as 4 weeks
Correlative studies
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
Number of Participants With Response
Response rate is the percentage of subjects with a confirmed complete or partial response using revised Response Evaluation Criteria in Solid Tumors (RECIST) where changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria: Complete Response (CR): Disappearance all target lesions; pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): 30% or \> decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): 20% or \> increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study); and sum must demonstrate absolute increase of 5+ mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.
Time frame: Baseline to 2 years
Disease Control Rate
Disease Control Rate is the proportion of subjects with a confirmed complete or partial response of any duration or stable disease ≥3 months in duration.
Time frame: Up to 2 years
Duration of Response
Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.
Time frame: From the date criteria are first met for complete or partial response until the first date of documented progression, assessed up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Durable Response Rate
Durable Response Rate is the proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration.
Time frame: Up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.