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Recruiting NCT06162377

Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.

Conditions: Head and Neck Squamous Cell Carcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 25
Sponsor: M.D. Anderson Cancer Center

Location: MD Anderson Cancer Center Houston Texas

Summary

To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.

Eligibility Criteria

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 \ 2 folds from normal levels * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Urgent or emergency surgery * Participants with known distant metastatic disease * Participants with primary brain tumors or brain metastases. Methylnaltrexone has poor penetration of the blood brain barrier and there is limited available data regarding the safety of the drug in participants with central nervous system tumors. * Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with methylnaltrexone, breastfeeding should be discontinued if the mother is treated with methylnaltrexone. These potential risks may also apply to other agents used in this study. * Peptic ulcer or intestinal perforation or colitis or other intestinal disorders such as Crohn's disease, diverticulitis, or Ogilvie's syndrome, intestinal obstruction or severe diarrhea because of risk of intestinal perforation. * Use of other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06162377). StuddyBuddy aggregates publicly available trial information.