Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Narcotic Antagonists

All Drugs and Chemicals

Analgesics

Central Nervous System Depressants

Methylnaltrexone

Narcotics

Participants will be given 14 pre-filled syringes of methylnaltrexone. Participants will be instructed how to take the drug as an injection under the skin of your abdominal area.

Juan Cata, MD

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

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.

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

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

M.D. Anderson Cancer Center

Symptoms and General Pathology

Substance Related Disorders

Behaviors and Mental Disorders

Constipation

Opioid-Related Disorders

Opioid-Induced Constipation

Signs and Symptoms, Digestive

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Anticonvulsants

Bromides

Analgesics, Opioid

A single dose of methylnaltrexone will be administered subcutaneously to eligible subjects based on weight at the study entry. Since we will include subjects at all stages of cancer management, administering this study drug is considered experimental. We will use the dose approved by FDA, i.e., 0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg.

Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose

Methylnaltrexone bromide

Steven Ades, MD

The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.

Pain is one of the most common and important symptoms of cancer, often requiring opioid analgesics for control. However constipation is one of the most frequent and debilitating side effects of opioids, occurring in 40%-70% of patients being treated for chronic pain. Although laxatives are commonly used to manage opioid-induced constipation, these agents are not always effective or satisfactory. Methylnaltrexone bromide is a peripherally acting antagonist of the mu-opioid receptor. As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is limited. This allows methylnaltrexone to function as a peripherally-acting antagonist in the gastrointestinal tract without impacting opioid-mediated analgesic effects in the central nervous system. The efficacy and safety of methylnaltrexone in treating opioid-induced constipation in patients with advanced disease receiving palliative care has been demonstrated. However the efficacy of this agent has not been evaluated in more active patients who are earlier in their disease course. The present study will evaluate the efficacy and safety of methylnaltrexone for the relief of severe opioid-induced constipation in this population and will attempt to identify factors predictive of methylnaltrexone response.

Methylnaltrexone for Opioid-induced Constipation in Cancer Patients

Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients

University of Vermont

Associate Professor

Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose

Age, Continuous

Sex: Female, Male

Masanori Mori, MD

Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone

Rescue-free Laxation within 24 hours (n=12)

Laxation within 48 hours (n=12)

Laxation After Administration of Subcutaneous Methylnaltrexone

Mean time to rescue-free laxation ≤4 hours (n=11)

Mean time to rescue-free laxation ≤24 hours (n=11)

Mean time to laxation ≤48 hours (n=11)

Time to Laxation After Administration of Subcutaneous Methylnaltrexone

Average pain (0-4 hours) (n=12)

Average pain (4-24 hours) (n=12)

Average pain (24-48 hours) (n=12)

Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone

0-4 hours (n=12)

4-24 hours (n=12)

24-48 hours (n=11)

Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone

Frequency of ≥ 1 laxation (0-4 hours) (n=12)

Frequency of ≥ 1 laxation (4-24 hours) (n=12)

Frequency of ≥ 1 laxation (24-48 hours) (n=11)

Consistency (slight-very hard) (0-4 hours) (n=12)

Consistency (slight-very hard) (4-24 hours) (n=12)

Consistency (slight-very hard)(24-48 hours) (n=11)

Difficulty (severe-very severe) (0-4 hours) (n=12)

Difficulty (severe-very severe)(4-24 hours) (n=12)

Difficulty (severe-very severe)(24-48hours) (n=11)

Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone

Severity (severe-very severe) (0-4 hours) (n=12)

Severity (severe-very severe) (4-24 hours) (n=12)

Severity (severe-very severe) (24-48 hours) (n=11)

Distress (severe-very severe) (0-4 hours) (n=12)

Distress (severe-very severe) (4-24 hours) (n=12)

Distress (severe-very severe) (24-48 hours) (n=11)

Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone

Satisfied-very satisfied (0-4 hours) (n=12)

Satisfied-very satisfied (4-24 hours) (n=12)

Satisfied-very satisfied (24-48 hours) (n=11)

Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone

Overall Study

Cancer Pain

Pain

methylnaltrexone

placebo

Jeff Cohn

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

Progenics Pharmaceuticals, Inc.

Bausch Health Americas, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.	NCT06162377	Head and Neck S...	Methylnaltrexon...	18 Years -	M.D. Anderson Cancer Center
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients	NCT01004393	Neoplasms Constipation Opioid-Related ...	Methylnaltrexon...	18 Years -	University of Vermont
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects	NCT00858754	Opioid-Induced ...	methylnaltrexon... placebo	18 Years - 90 Years	Bausch Health Americas, Inc.
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients	NCT01004393	Neoplasms Constipation Opioid-Related ...	Methylnaltrexon...	18 Years -	University of Vermont

Spots Global Cancer Trial Database for methylnaltrexone