What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as radiation therapy and chemotherapy, have several known side effects. Radiation therapy can cause mucositis, xerostomia (dry mouth), dysphagia (difficulty swallowing), skin reactions, and fatigue. Chemotherapy, often combined with radiation, can lead to nausea, vomiting, neutropenia (low white blood cell count), anemia, thrombocytopenia (low platelet count), and increased infection risk. Specific agents like cisplatin can cause nephrotoxicity (kidney damage) and ototoxicity (hearing loss), while cetuximab can result in skin reactions and infusion-related reactions.

What prior FDA approvals exist?

FDA-approved treatments for head and neck cancers often involve targeted therapies and immunotherapies that utilize genetic and biomarker analysis to guide treatment. Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, has been approved for use in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with high PD-L1 expression. Cetuximab, an EGFR inhibitor, is another approved targeted therapy for HNSCC. These treatments are aligned with the investigational approaches in the trial involving additional MRIs and biomarker testing to predict tumor response.

What other types of research exist?

Promising, novel alternatives for head and neck cancer patients considering treatment in 2024 include the use of chimeric antigen receptor (CAR)-expressing T cells, oncolytic adenoviruses like DNX-2401, and novel pharmacologic inhibitors targeting specific genetic mutations. These approaches are being investigated in other cancers and may offer new avenues for treatment and diagnosis in head and neck cancers.

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MRI and Biomarker Monitoring for Head and Neck Cancer

N/A

Waitlist Available

Led By Clifton D Fuller

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2

For females of child-bearing age, a negative pregnancy test

Must not have

Contraindications to gadolinium contrast

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find ways to predict how tumors in the head and neck respond to treatment. The goal is to improve understanding of tumor responses and plan better treatments.

Who is the study for?

This trial is for adults with certain head and neck cancers who haven't had distant metastases or previous radiation treatments in the affected area. They should be fit enough for curative radiotherapy, not pregnant, and able to undergo MRI scans without contraindications like metal implants or severe kidney issues.

What is being tested?

Researchers are testing if additional MRIs and blood biomarker analysis can predict tumor changes during radiation therapy. Participants will have extra scans and blood tests beyond standard care to see if these methods improve understanding of treatment response.

What are the potential side effects?

There may be minimal side effects related to MRI procedures such as discomfort from lying still. Blood draws might cause bruising or infection at the puncture site. Gadolinium contrast used in MRIs could pose risks for those with kidney problems.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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I am of child-bearing age and my pregnancy test is negative.

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My cancer has not spread to distant parts of my body.

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I have been diagnosed with squamous cell carcinoma in the head or neck.

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I am scheduled for radiotherapy aimed at curing my condition.

Exclusion Criteria

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

Select...

I cannot have gadolinium contrast due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT)

Change in TK

Tumor growth velocity (TGV)

Secondary study objectives

Locoregional control

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293

19%

87900-Vomiting(targeted toxicity)

15%

11400-Agitation

58700-Nystagmus

16800-Bladder infection

11600-Alanine aminotransferase increased

44800-Infections and infestations - Other specify

58300-Neutrophil count decreased

41400-Hyperglycemia(targeted toxicity)

69700-Rash maculo-papular(targeted toxicity)

33900-Fever

33300-Febrile neutropenia

20500-Catheter related infection

42600-Hypoalbuminemia

43100-Hypokalemia

88500-White blood cell decreased

41300-Hypercalcemia

42700-Hypocalcemia

15300-Ataxia

64400-Personality change

13200-Anemia

57600-Nausea(targeted toxicity)

13500-Anorexia

15000-Aspartate aminotransferase increased

25700-Diarrhea

41600-Hyperkalemia

41500-Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Chemotherapy, Immunoglobulin Therapy)

Arm II (Chemotherapy, Observation)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (MRI, blood sample collection)Experimental Treatment4 Interventions

Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 6Eligibility 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 Cancers include radiation therapy, chemotherapy, and targeted therapies. Radiation therapy damages the DNA of cancer cells, leading to their death. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, such as cetuximab, inhibit specific molecules involved in cancer cell growth and survival. These mechanisms are important for patients as they help predict treatment response and enable personalized treatment plans, especially when combined with advanced imaging and biomarker testing.

Clinical correlation of opposing molecular signatures in head and neck squamous cell carcinoma.