Actively Recruiting
Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.
Led by M.D. Anderson Cancer Center · Updated on 2025-12-17
25
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.
CONDITIONS
Official Title
Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically-confirmed oral cavity squamous cell carcinoma (T1-T4, N any) amenable to curative-intent surgery
- Able to receive the study drug for at least two weeks before surgery
- Willing and able to comply with scheduled visits, treatment plans, lab tests, and other study procedures
- Women of child-bearing potential and men must agree to use adequate contraception during the study unless exempt due to postmenopausal status, surgical sterilization, or ovarian failure
- Ability to understand and sign written informed consent
You will not qualify if you...
- Receiving any other investigational agents
- Non-English or non-Spanish speaking
- History of allergic reactions to methylnaltrexone or similar compounds
- Uncontrolled illness including chronic kidney disease (eGFR <60 ml/min) or liver disease with elevated enzymes or bilirubin
- Psychiatric illness or social situations limiting study compliance
- Urgent or emergency surgery
- Known distant metastatic disease
- Primary brain tumors or brain metastases
- Pregnant or breastfeeding women
- Peptic ulcer, intestinal perforation, colitis, Crohn's disease, diverticulitis, Ogilvie's syndrome, intestinal obstruction, or severe diarrhea
- Use of other opioid antagonists
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Juan Cata, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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