Mitomycin C for Head and Neck Cancer

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mitomycin C, a cancer-fighting drug, can benefit individuals with head and neck cancer unresponsive to other treatments. The focus is on those whose cancer has progressed despite prior therapies such as platin, 5-FU, cetuximab, and taxane. The trial includes two groups, each receiving mitomycin C every five weeks, along with a supportive injection of pegfilgrastim to boost white blood cells. Suitable candidates for this trial have head and neck squamous cell carcinoma considered incurable and have experienced worsening after previous treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mitomycin C can be safely used with radiation therapy for head and neck cancer, without increasing harmful side effects. One study found that combining mitomycin C with 5-Fluorouracil, a chemotherapy drug, effectively treated head and neck cancer without major safety issues.

These studies suggest that mitomycin C is generally well-tolerated. However, it is important to note that this is a Phase 2 trial. The treatment has demonstrated some safety in earlier research, but more information is needed to fully understand its safety in larger groups. Always consult your doctor before joining a clinical trial to determine if it is suitable for you. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Mitomycin C for head and neck cancer because it offers a different approach compared to standard treatments like surgery, radiation, and chemotherapy. Mitomycin C works by cross-linking DNA, which disrupts cancer cell replication, potentially enhancing effectiveness against tumors. In this trial, it's paired with Pegfilgrastim, which supports the immune system by stimulating white blood cell production, possibly reducing treatment-related side effects. This combination could improve outcomes and quality of life for patients with head and neck cancer.

What evidence suggests that mitomycin C might be an effective treatment for head and neck cancer?

Research has shown that mitomycin-C can help treat certain cancers. One study found that adding mitomycin-C to radiation therapy increased the chance of the cancer not returning from 66% to 87%, meaning fewer cancers returned with this combination. Mitomycin-C targets and kills cancer cells with low oxygen levels. It has also demonstrated a 35% success rate when administered in high doses. In this trial, participants will receive mitomycin-C as part of their treatment regimen. These findings suggest that mitomycin-C might be useful in treating head and neck cancers. ^{3 6 7 8 9}

Who Is on the Research Team?

Peter Oppelt, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161199/

Phase I study of continuous mitomycin-C infusion in ... Conclusions: Our study demonstrates that continuous infusion of 5-FU/MMC can be safely administered at a MMC dose of 3.21 mg/m²/day on days 1–5 and 36–40 in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/0360301689903623

Randomized clinical trial of mitomycin c as an adjunct to ... Local recurrence-free survival was 66% in the radiation therapy group and 87% in the radiation therapy plus mitomycin C group, p < 0.02. The findings ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10439743/

A Pilot Study Exploring the Role of Injection Mitomycin C on ... This study aimed to investigate the use of injection MMC as a local application on surgical resection beds for patients undergoing surgery for oral cancer

4. elischolar.library.yale.edu elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1283&context=ymtdl

Post-Operative Concurrent Chemoradiation with Mitomycin-C ... Mitomycin-C is a hypoxic cell cytotoxin that has been shown to be synergistically effective with radiation in controlling disease.

5. withpower.com withpower.com/trial/phase-3-squamous-cell-carcinoma-of-head-and-neck-3-2015-a1e94

Mitomycin C for Head and Neck Cancer · Info for Participants 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), ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT02369458

Mitomycin C in Patients With Incurable p16 Positive ... Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10546034/

Locally advanced head and neck squamous cell ... This study summarized and compared multiple treatment options for LA-HNSCC to assess treatment efficacy and safety. ... mitomycin C+5-Fluorouracil ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6682352/

Characterization of the tumor immune micromilieu and its ... Thirty-three OPSCC cases from the cisplatin-based CRTX (CDDP-CRTX) arm and 31 OPSCC cases from the mitomycin C-based CRTX (MMC-CRTX) arm of the ARO-0401 trial ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02369458/mitomycin-c-in-patients-with-incurable-p16-positive-oropharyngeal-and-p16-negative-head-and-neck-squamous-cell-carcinoma-hnscc-resistant-to-standard-therapies

Mitomycin C in Patients With Incurable p16 Positive ... No agent is known to have efficacy in patients with incurable HNSCC that progressed with prior platin, 5-FU, cetuximab and taxane.