Doxycycline, Temozolomide and Ipilimumab in Melanoma
The goal of this clinical research study is to find the highest tolerable dose of doxycycline that can be combined with temozolomide and ipilimumab in patients with advanced melanoma. The safety and level of effectiveness of the study drug combination will also be studied.
Doxycycline is designed to treat bacterial infection. It also blocks a protein called iNOS that is important in tumor cell growth, which may slow the growth of or kill cancer cells.
Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.
Ipilimumab is designed to block the activity of cells that decrease the immune system's ability to fight cancer.
|Melanoma||Drug: Doxycycline Drug: Ipilimumab Drug: Temozolomide||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I / II Study of the Combination of Doxycycline With Temozolomide and Ipilimumab in Patients With Metastatic Melanoma|
- Overall Response Rate [ Time Frame: 2 cycles ]Overall survival (OS) and time to progression (TTP) calculated using Kaplan-Meier method. Overall response rate at end of study also calculated. Response rate calculated using point estimate, together with 95% confidence interval (CI). Kaplan-Meier method used to estimate progression free survival (PFS) time. PFS defined as time interval between start of treatment to date of disease progression, or death. Response Evaluation Criteria in Solid Tumors ( RECIST) version 1.1 used to evaluate response rate.
|Study Start Date:||November 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Doxycycline + Ipilimumab + Temozolomide
Doxycycline to start on day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts) twice a day until morning of Day 1 of Cycle 1. After the Day 1 of Cycle 1, participants receive first dose of Ipilimumab, and evening of same day, Temozolomide received by mouth once a day for 4 days. Doxycycline administration will continue twice daily for rest of cycle without interruption; Cycle 1 is 4 weeks of treatment. Starting Cycle 2, Doxycycline with temozolomide and ipilimumab administration start on Day 1. Each cycle is 3 weeks. 4 cycles of therapy given over a 3 month period to complete induction phase. After induction therapy, participants continue on Doxycycline.
Phase I Starting Dose: 200 mg by mouth twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts)
Phase II Starting Dose: Maximum Tolerated Dose (MTD) from Phase I.
Phase I and II: 3 mg by vein on Day 1 of each 21 day cycle for 4 cycles.
Other Names:Drug: Temozolomide
Phase I and II: 200 mg/m2 by mouth on Days 1 - 4 of each 21 day cycle for 4 cycles.
Other Name: Temodar
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01590082
|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|