NCT06162377

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 candidates for OCSCC. 2.3 Exploratory Objectives The exploratory objectives are to perform tumor RNASeq profiling and assess blood and tumor immunological landscape, and to correlate efficacy endpoints with tumor biomarkers.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Methylnaltrexone	Given by SC (injection)

Timeline

• Start date: 2024-01-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-12-08
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study