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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Methylnaltrexone
DrugGiven by SC (injection)
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: MethylnaltrexoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov