Mitomycin C for Head and Neck Cancer

Palo Alto (17 mi)

Overseen byPeter Oppelt, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

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.

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

My cancer can be measured by scans or physical exam.

My cancer is in the head or neck area and cannot be cured with surgery or has spread.

My cancer progressed after treatment with platinum and immunotherapy.

My kidney function is normal or only slightly above normal.

I can care for myself but may not be able to do any physical work.

I have tissue available for p16 testing.

I am 18 years old or older.

Exclusion Criteria

I do not have any serious illnesses that could interfere with the study.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Group I: Cohort A: p16+ OPSCCExperimental Treatment2 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- HNSCCExperimental Treatment2 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: