← Back to Search

Alkylating agents

Mitomycin C for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Peter Oppelt, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam per RECIST 1.1.

Histologically or cytologically confirmed incurable HNSCC of the oral cavity, oropharynx, larynx, hypopharynx, and/or Level 1-3 neck node with non-cutaneous SCC and unknown primary. "Incurable" is defined as metastatic disease or a local or regional recurrence in a previously irradiated site that is unresectable (or patient declines resection).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)

Awards & highlights

Study Summary

This trial is testing whether mitomycin C will be effective in treating patients with incurable head and neck squamous cell carcinoma who have progressed after treatment with platin, 5-FU, cetuximab, and taxane.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Mitomycin-C can cause side effects such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. Pegfilgrastim might cause bone pain or pain at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer can be measured by scans or physical exam.

Select...

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

Select...

My cancer progressed after treatment with platinum and immunotherapy.

Select...

My kidney function is normal or only slightly above normal.

Select...

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

Select...

I have tissue available for p16 testing.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months (median 5.6 months with full range of 0.1-33.7 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor Response Rate (TRR)

Tumor Response Rate (TRR) for Participants Enrolled Post October 2020

Secondary outcome measures

Number of Participants With Grade 3/4/5 Adverse Events

Overall Survival (OS)

Progression-free Survival (PFS)

Other outcome measures

Quality of Life as Measured by the Cognitive Failures Questions (CFQ)

Quality of Life as Measured by the EORTC QLQ-C30

Side effects data

From 2017 Phase 2 trial • 100 Patients • NCT02016898

31%

Wound leak

31%

Hypotony

11%

Cystic blebs

Choroidal effusion

Shallowing of anterior chamber

Hyphema

Suprachoroidal hemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Irrigation Placement of Mitomycin-C

Sponge Placement of Mitomycin-C

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitomycin-C

2011

Completed Phase 2

~240

Pegfilgrastim

2013

Completed Phase 3

~4410

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,661 Total Patients Enrolled

Peter Oppelt, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

Mitomycin-C (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02369458 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Cohort 2: p16- HNSCC, Cohort A: p16+ OPSCC

Squamous Cell Carcinoma Clinical Trial 2023: Mitomycin-C Highlights & Side Effects. Trial Name: NCT02369458 — Phase 2

Mitomycin-C (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02369458 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other trials exploring the efficacy of Mitomycin-C?

"Currently, 77 trials are exploring the efficacy of Mitomycin-C. Notably 21 of those experiments are in Phase 3. Princeton, Illinois is home to multiple studies surrounding this medication; however there exists 4393 additional sites across the world hosting their own investigations into its effectiveness."

Answered by AI

Are additional participants being accepted for this research endeavor?

"This medical experiment is no longer accepting participants, having last been updated on June 21st 2022. On the other hand, there are currently 2676 trials looking for people with carcinoma squamous cell and 77 studies actively recruiting patients who would receive Mitomycin-C as a treatment intervention."

Answered by AI

What indications are treated by Mitomycin-C?

"Mitomycin-C is an effective therapeutic option for patients with cervical cancer, low-grade upper tract urothelial cancer (lg-utuc), and glaucoma."

Answered by AI

What potential adverse effects should be considered before utilizing Mitomycin-C?

"The safety profile of Mitomycin-C has been evaluated at a score 2, since this is still an experimental Phase 2 trial without any evidence regarding its efficacy."

Answered by AI

What is the size of the patient sample for this research endeavor?

"Unfortunately, this clinical trial has concluded its recruitment phase. Initially posted on April 14th 2015 and last updated June 21st 20202, the study is no longer open for applications. However, there are 2676 studies currently recruiting participants with carcinoma squamous cell cancer and 77 trials that utilize Mitomycin-C in their interventions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02369458.

All > Hnscc > Squamous Cell Carcinoma