Mitomycin C for Head and Neck Cancer

Overseen By Peter Oppelt, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: Investigational agents, Antiretrovirals

Disqualifiers: Active malignancy, CNS metastases, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 months

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is evaluating whether a drug which has been used for decades to treat cancer may have the potential to help patients with incurable head and neck cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving any other investigational agents or if you are HIV-positive on combination antiretroviral therapy.

What evidence supports the effectiveness of the drug Mitomycin C for head and neck cancer?

Research shows that adding Mitomycin C to radiation therapy for head and neck cancer improves local tumor control and increases disease-free survival rates compared to radiation therapy alone. ^{1 2 3 4 5}

Is Mitomycin C safe for use in humans?

Mitomycin C has been used safely in combination with radiation therapy for head and neck cancer, showing no increase in normal tissue reactions. However, it can cause some side effects like blood and lung issues, and if not administered correctly, it can damage skin tissue. In breast cancer treatment, it has been associated with mild nausea and vomiting, and more serious effects like blood, lung, kidney, and heart problems over time. ^{1 2 3 6 7}

How is the drug Mitomycin C unique in treating head and neck cancer?

Mitomycin C is unique because it is an antimitotic drug that can be used in combination with accelerated radiation therapy to potentially enhance treatment effectiveness. It also has the ability to reduce scar formation and fibrosis, which can be beneficial in managing post-operative complications in head and neck cancer. ^{1 2 5 8 9}

Research Team

Peter Oppelt, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults with incurable head and neck squamous cell carcinoma (HNSCC) that has worsened despite previous treatments. Participants must have proper liver, kidney, and blood function, agree to use contraception, and not be pregnant or breastfeeding. Those with controlled brain metastases may qualify.

Inclusion Criteria

Platelets ≥ 75,000/mcl

My liver function tests are within acceptable limits, unless I have bone metastasis without liver involvement.

My cancer can be measured by scans or physical exam.

Exclusion Criteria

I am HIV-positive and on antiretroviral therapy.

You are currently taking any experimental medications.

I have no active cancer except for certain skin cancers, cervical carcinoma in situ, or specific head and neck cancers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mitomycin C is administered on Day 1 every 5 weeks, with Pegfilgrastim given on Day 2 of each cycle

6 months

Every 5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 3 months

Treatment Details

Interventions

• Mitomycin-C
• Pegfilgrastim

Trial Overview The study tests Mitomycin-C's effectiveness in patients whose HNSCC hasn't responded to standard therapies like platin, 5-FU, cetuximab, and taxane. Pegfilgrastim is also used to support white blood cell counts during treatment.

Participant Groups

Group I: Cohort A: p16+ OPSCC Experimental Treatment 2 Interventions

* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks). * Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)

Group II: Cohort 2: p16- HNSCC Experimental Treatment 2 Interventions

* Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks). * Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)

Mitomycin-C is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Mitomycin-C for:

• Anal cancer
• Stomach cancer
• Pancreatic cancer

Approved in United States as Mitomycin-C for:

• Anal cancer
• Stomach cancer
• Pancreatic cancer

Approved in Canada as Mitomycin-C for:

• Anal cancer
• Stomach cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

Mitomycin-C, an antitumor antibiotic, has shown an overall response rate of 35% when administered intermittently at high doses (20 mg/m2 every 6 to 8 weeks), making it an effective treatment option for certain cancers.

While acute toxicities like mild nausea and vomiting are manageable, chronic toxicities such as myelosuppression and pulmonary toxicity require careful monitoring, especially when incorporating mitomycin-C into breast cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitomycin-C in breast cancer. Hortobagyi, GN.[2018]

References

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

Continuous hyperfractionated accelerated radiotherapy with/without mitomycin C in head and neck cancer. [2019]

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

Evidence-based applications of mitomycin C in the nose. [2018]

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

Randomized clinical trial of mitomycin C as an adjunct to radiotherapy in head and neck cancer. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Radiotherapy with or without mitomycin c in the treatment of locally advanced head and neck cancer: results of the IAEA multicentre randomised trial. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[The topical application of mitomycin C in the treatment of scar formation and stenosis in hollow organs of the head and neck: a field report]. [2013]

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

Accidental Extravasation of Mitomycin C into the Subcutaneous Tissue. [2023]

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

Mitomycin-C in breast cancer. [2018]

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

Effect of mitomycin C on the size of antrostomy after endoscopic sinus surgery. [2017]

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

Role of mitomycin in upper digestive tract stricture. [2022]