Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye
|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||Biological: Cixutumumab Other: Laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of IMC-A12 in Metastatic Uveal Melanoma|
- Response Rate (% Participants With Complete or Partial Response) [ Time Frame: Baseline to 2 years ]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.
- Disease Control Rate (i.e., 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 ]The disease control rate will be presented and the adjusted 95% confidence interval will be calculated.
- Durable Response Rate (i.e., the Proportion of Subjects With a Confirmed Complete or Partial Response ≥ 6 Months in Duration) [ Time Frame: Up to 2 years ]The durable response rate will be presented and the adjusted 95% confidence interval will be calculated.
- Duration of Response [ 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 ]Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.
- Progression-free Survival (PFS) [ Time Frame: Up to 2 years ]
- Overall Survival (OS) [ Time Frame: Up to 2 years ]
- Tumor Shrinkage for All Efficacy-evaluable Patients [ Time Frame: Up to 2 years ]
|Study Start Date:||August 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
10 mg/kg IV infusion over 1 hour every 2 weeks with treatment cycle defined as 4 weeks
Other Names:Other: Laboratory biomarker analysis
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413191
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sapna Patel||M.D. Anderson Cancer Center|