Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.
Eligibility criteria
Qualifiers
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
Disqualifiers
Participants who are receiving any other investigational agents.
Non-English/Non-Spanish speaking participants.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to methylnaltrexone or other agents used in the study.
Participants with uncontrolled intercurrent illness, including chronic kidney disease defined as a eGRF <60 ml/mim, and liver disease defined as transaminitis > 2 folds from normal levels, cirrhosis and hyperbilirubinemia > 2 folds from normal levels
Trial design
Treatments tested in this trial
- Methylnaltrexone
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
1MD Anderson Cancer Center77030, HoustonTexas, United States
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Source ClinicalTrials.gov