What is the mechanism of action of this treatment?

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include surgery, radiation therapy (RT), chemotherapy, and immunotherapy. Surgery involves the physical removal of the tumor, aiming to eliminate cancerous cells from the body. Radiation therapy uses high-energy rays to destroy cancer cells by damaging their DNA, which is crucial for controlling locoregional disease. Chemotherapy, often used in combination with RT (as in CCRT), employs cytotoxic drugs like cisplatin to kill rapidly dividing cells, including cancer cells. Immunotherapy, such as the use of checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells. These treatments are essential for HNSCC patients as they target the cancer through different mechanisms, improving the chances of controlling or eradicating the disease. The MIT-001 trial focuses on preventing oral mucositis, a common and painful side effect of CCRT, highlighting the need for supportive care to improve patient quality of life during treatment.

What side effects are associated with this type of intervention?

Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include surgery, radiation therapy, and chemoradiotherapy (CCRT). The side effects of these treatments can be significant. Chemoradiotherapy often leads to oral mucositis, a painful inflammation and ulceration of the mucous membranes in the mouth. Other side effects include xerostomia (dry mouth), dysphagia (difficulty swallowing), and changes in taste. Radiation therapy can cause skin reactions, fatigue, and long-term issues such as fibrosis and dental problems. Systemic chemotherapy may result in nausea, vomiting, hair loss, and increased susceptibility to infections. These side effects can significantly impact the patient's quality of life and require comprehensive management.

What prior FDA approvals exist?

The FDA has approved several treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) that are used in combination with radiation therapy or as part of chemoradiotherapy regimens. Notably, cetuximab, an EGFR-targeting monoclonal antibody, has been approved for use with definitive radiation therapy, showing significant improvements in locoregional control and overall survival. Additionally, cisplatin, often used in combination with radiation therapy, is a standard chemotherapeutic agent for HNSCC. These treatments are relevant to the context of the MIT-001 trial, which focuses on preventing oral mucositis in patients undergoing similar concurrent chemoradiotherapy regimens.

What other types of research exist?

Promising novel alternatives to MIT-001 for the prevention of oral mucositis in HNSCC patients include SCV-07, zinc supplementation, comprehensive oral management protocols, and photobiomodulation therapy.

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MIT-001 for Oral Mucositis Prevention in Head and Neck Cancer Patients (MIT-001 Trial)

Phase 2

Recruiting

Research Sponsored by MitoImmune Therapeutics

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less

Histologically confirmed HNSCC (The American joint committee on cancer [AJCC] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx, or HPV-positive Stage I oropharyngeal cancer.

Must not have

Patients who have active mucositis at screening.

Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first treatment to 2 months of safety follow-up period after ccrt completion

Summary

This trial tests MIT-001, a drug that reduces harmful molecules to prevent inflammation, in patients with advanced head and neck cancer undergoing chemoradiotherapy. The goal is to prevent painful mouth sores by protecting cells and blocking inflammation pathways.

Who is the study for?

This trial is for adults with a specific type of throat cancer (HNSCC) that hasn't been treated yet. They should be in good physical shape, not pregnant, and planning to get standard chemo with cisplatin and targeted radiation therapy. People can't join if they've had recent surgery for HNSCC, have active mouth sores, severe allergies to platinum drugs like cisplatin, or any other serious health issues.

What is being tested?

The study tests MIT-001's ability to prevent mouth sores caused by chemoradiotherapy in throat cancer patients. Participants will receive one of three different doses of MIT-001 or a placebo alongside their standard cancer treatment regimen.

What are the potential side effects?

Potential side effects are not specified but may include reactions related to the prevention or management of oral mucositis as well as typical side effects from concurrent chemoradiotherapy.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can carry out all my usual activities without help.

Select...

My cancer is in the mouth or throat and is either at an advanced stage or HPV-positive.

Select...

I am scheduled for weekly cisplatin treatments for 5 to 7 weeks.

Select...

I am scheduled for a specific radiation therapy for head and neck cancer, targeting over 30% of my mouth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have mouth sores.

Select...

I am allergic or have had a severe reaction to cisplatin or similar drugs.

Select...

My cancer originates from the lips, sinuses, salivary glands, or is of unknown primary origin.

Select...

My cancer has spread to other parts of my body.

Select...

I am planned to receive targeted or immune therapy, such as Erbitux, during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first treatment to 2 months of safety follow-up period after ccrt completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first treatment to 2 months of safety follow-up period after ccrt completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first treatment to 2 months of safety follow-up period after ccrt completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of severe OM

Secondary study objectives

Analgesic use for OM

Incidence of OM

Mouth pain and discomfort

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 60 mgExperimental Treatment1 Intervention

MIT-001 60 mg

Group II: 40 mgExperimental Treatment1 Intervention

MIT-001 40 mg

Group III: 20 mgExperimental Treatment1 Intervention

MIT-001 20 mg

Group IV: PlaceboPlacebo Group1 Intervention

Matching placebo

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include surgery, radiation therapy (RT), chemotherapy, and immunotherapy. Surgery involves the physical removal of the tumor, aiming to eliminate cancerous cells from the body. Radiation therapy uses high-energy rays to destroy cancer cells by damaging their DNA, which is crucial for controlling locoregional disease. Chemotherapy, often used in combination with RT (as in CCRT), employs cytotoxic drugs like cisplatin to kill rapidly dividing cells, including cancer cells. Immunotherapy, such as the use of checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells. These treatments are essential for HNSCC patients as they target the cancer through different mechanisms, improving the chances of controlling or eradicating the disease. The MIT-001 trial focuses on preventing oral mucositis, a common and painful side effect of CCRT, highlighting the need for supportive care to improve patient quality of life during treatment.