Mitomycin C for Head and Neck Cancer

Recruiting in 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

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.

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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.

See 4 more

Treatment Details

Interventions

Mitomycin-C (Alkylating agents)
Pegfilgrastim (Growth Factor)

Trial OverviewThe 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

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: