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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A "Window of Opportunity" Pilot Study.
ClinicalTrials.gov ID: NCT06162377
What this study is testing
What is Methylnaltrexone?
Methylnaltrexone is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for head and neck squamous cell carcinoma.
Also referred to as Relistor™.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
- The effects of methylnaltrexone on the developing human fetus are unknown. For this reason and because methylnaltrexone agents as well as other...
You likely can't join if
- 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...
- Participants with uncontrolled intercurrent illness, including chronic kidney disease defined as a eGRF \ 2 folds from normal levels, cirrhosis and...
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are...
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
See the full eligibility criteria
- 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
- The effects of methylnaltrexone on the developing human fetus are unknown. For this reason and because methylnaltrexone agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Ability to understand and the willingness to sign a written informed consent document.
- 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 \ 2 folds from normal levels, cirrhosis and hyperbilirubinemia \> 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...
- 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...
- 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...
- Use of other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.