Ipilimumab + Temozolomide in Metastatic Melanoma
The goal of this clinical research study is to learn if combining ipilimumab and temozolomide can help to control metastatic melanoma. The safety of this drug combination will be studied. Researchers would also like to study how this therapy affects the levels of certain chemicals in the blood that are related to your immune system.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Ipilimumab Plus Temozolomide in Patients With Metastatic Melanoma|
- 6-Month Progression-Free Survival (PFS) Rate [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Progression-free survival estimated using method of Kaplan-Meier. PFS determined from the start of study until disease progression or death, whichever is first. All patients who do not have a disease progression or death censored on their last evaluable tumor assessment date. PFS rate at 6 month provided with its 95% confidence interval estimated using bootstrap method. Median PFS reported together with a two-sided 95% CI calculated using method of Brookmeyer and Crowley. Cox's proportional hazard model used to determine the relationship with PFS and the potential prognostic factors. Exploratory logistic regression used to identify prognostic factors that are significantly correlated with PFS rate at 6 months.
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Experimental: Ipilimumab + Temozolomide
Induction: Ipilimumab 10 mg/kg IV over 90 minutes Day 1 + Temozolomide 200 mg/m2 PO on Days 1 - 4, every 3 weeks for 4 courses over 3 months.
Induction Phase: 10 mg/kg by vein (IV) over approximately 90 minutes on Day 1 only repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose repeated every 12 weeks.
Other Names:Drug: Temozolomide
Induction Phase, 200 mg/m^2 by mouth (PO) on Days 1 to 4, repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose delivered on Days 1 to 5, repeated every 4 weeks.
Other Name: Temodar
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01119508
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sapna P. Patel, MD||M.D. Anderson Cancer Center|