Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.
M.D. Anderson Cancer Center
Summary
To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.
Description
2.1 Primary Objectives The primary objective of this study is to evaluate the feasibility of treating OCSCC participants with methylnaltrexone. We define success as when a participants can receive assigned medication for two weeks preoperatively without interruption due to AEs (NCI CTCAE v4.03). By the end of the trial, feasibility is claimed if 90% or above the participants can successfully receive assigned medication. 2.2 Secondary Objectives The secondary objectives are to evaluate the endpoints include tolerability, efficacy and tumor biological response of methylnaltrexone in surgical…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 years of age or older. Because no dosing or adverse event data are currently available on the use of methylnaltrexone in participants \<18 years of age, children are excluded from this study. * Histologically-confirmed oral cavity squamous cell carcinoma \[(T1-T4, N (any)\] that is amenable to curative-intent surgery * Able to receive the study drug for at least two weeks preoperatively * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * The effects of methylnaltrexone on the developing human fetus…
Interventions
- DrugMethylnaltrexone
Given by SC (injection)
Location
- MD Anderson Cancer CenterHouston, Texas