Methylnaltrexone for Head and Neck Cancer

Overseen By Juan Cata, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Opioid antagonists

Disqualifiers: Non-English/Spanish, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

25 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use other opioid antagonists during the study. It's best to discuss your current medications with the study team to ensure they don't interfere with the trial.

How does the drug Methylnaltrexone differ from other treatments for head and neck cancer?

Methylnaltrexone is unique because it is primarily used to treat opioid-induced constipation by blocking opioid effects in the gut without affecting pain relief. Its use in head and neck cancer is novel, as it may help manage side effects of opioid pain medications commonly used in cancer care, potentially improving patients' quality of life. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Juan Cata, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with confirmed oral cavity squamous cell carcinoma that can be surgically removed. Participants must be able to take methylnaltrexone for two weeks before surgery, follow the study plan, and use approved birth control. Excluded are those on other trials, with allergies to similar drugs, uncontrolled illnesses like kidney or liver disease, HIV patients not on effective therapy, mental/social issues affecting compliance, urgent surgeries needed, metastatic disease or brain tumors present.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

My oral cancer is confirmed and can be treated with surgery aimed at curing it.

I can take the study medication for at least two weeks before surgery.

Exclusion Criteria

I need surgery urgently or as an emergency.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to methylnaltrexone or other agents used in the study

I do not speak English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methylnaltrexone for 2 weeks before surgery

2 weeks

Participants are instructed on self-administration of injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Methylnaltrexone

Trial Overview The MINK study tests if it's safe to give methylnaltrexone to patients with head and neck cancer for two weeks before their surgery. The goal is to see how well they tolerate the drug in this short period.

Participant Groups

Group I: Methylnaltrexone Experimental Treatment 1 Intervention

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.

Methylnaltrexone is already approved in United States, European Union for the following indications:

Approved in United States as Relistor for:

• Opioid-induced constipation in adult patients with chronic non-cancer pain

Approved in European Union as Relistor for:

• Opioid-induced constipation in adult patients with chronic non-cancer pain

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC), treatment options have evolved but survival rates remain largely unchanged, highlighting the need to balance treatment efficacy with patient quality of life.

For patients with high PD-L1 expression (CPS ≥ 20), pembrolizumab is recommended, while those with lower expression may benefit from combinations like pembrolizumab with cisplatin and 5FU, or the EXTREME regimen, which includes cetuximab, depending on affordability and support availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative chemotherapy in head and neck cancer: balancing between beneficial and adverse effects. Rajendra, A., Noronha, V., Joshi, A., et al.[2021]

Cytotoxic chemotherapy for recurrent and/or metastatic head and neck squamous cell cancer (R/M HNSCC) primarily includes platinum agents, taxanes, and antimetabolic agents, which are commonly used to manage the disease.

Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor, shows modest effectiveness in treating R/M HNSCC, highlighting the importance of a multidisciplinary approach in palliative care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current recommendations for systemic therapy of recurrent and/or metastatic head and neck squamous cell cancer. Fury, MG., Pfister, DG.[2019]

The EXTREME regimen, which combines cetuximab with platinum and 5-fluorouracil, remains the standard treatment for previously untreated patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Nivolumab, an anti-PD-1 monoclonal antibody, is now considered the standard of care for patients with R/M HNSCC who have progressed after platinum-based therapy, showing a survival benefit over other treatments in the CheckMate 141 trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing treatments for recurrent or metastatic head and neck squamous cell carcinoma. Specenier, P., Vermorken, JB.[2019]

The EXTREME regimen, which combines cetuximab with cisplatin and 5-fluorouracil, has significantly improved overall response rates and survival outcomes for patients with recurrent/metastatic head and neck cancer, making it the standard first-line treatment.

Recent advancements in treatment options, particularly immune checkpoint inhibitors like nivolumab and pembrolizumab, have shown promising results in extending overall survival for patients in later treatment lines, with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy and immunotherapy for recurrent and metastatic head and neck cancer: a systematic review. Guidi, A., Codecà, C., Ferrari, D.[2022]

In a phase II trial involving 32 patients with recurrent or metastatic squamous carcinoma of the head and neck, topotecan was administered but failed to show any responses in either chemonaive or previously treated patients.

The treatment resulted in significant side effects, including grade III/IV neutropenia in 16% and anemia in 18% of patients, and the median survival was only 4.6 months for chemonaive patients and 3.2 months for those previously treated, indicating a lack of efficacy and prompting the decision not to pursue further evaluation of topotecan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of efficacy of topotecan in the treatment of metastatic or recurrent squamous carcinoma of the head and neck: an Eastern Cooperative Oncology Group Trial (E3393). Murphy, BA., Leong, T., Burkey, B., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Palliative chemotherapy in head and neck cancer: balancing between beneficial and adverse effects. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Current recommendations for systemic therapy of recurrent and/or metastatic head and neck squamous cell cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Optimizing treatments for recurrent or metastatic head and neck squamous cell carcinoma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy and immunotherapy for recurrent and metastatic head and neck cancer: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lack of efficacy of topotecan in the treatment of metastatic or recurrent squamous carcinoma of the head and neck: an Eastern Cooperative Oncology Group Trial (E3393). [2019]