Local Injection Methylene Blue Combined With Radiation in HNSCC Patients

NCT07435415 | Active Not Recruiting Early Phase 1

• 1 other identifier: CMUH114-REC1-108
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of Methylene Blue (MB) as a radiosensitizer in treating head and neck squamous cell carcinoma (HNSCC) that has recurred locally and is resistant to radiation therapy. It will also assess the safety of Methylene Blue. The main questions it aims to answer are: Does Methylene Blue improve the outcomes for patients with recurrent HNSCC receiving radiation therapy? What side effects do participants experience while receiving Methylene Blue? Participants will: Receive weekly injections of Methylene Blue or placebo into the tumor over six weeks. Undergo six weeks of concurrent radiation therapy. Be monitored regularly for treatment effects and document any side effects experienced during the trial. This single-center clinical trial intends to recruit 10 eligible patients diagnosed with locoregional recurrence of HNSCC that is resistant to previous radiotherapy.

Conditions

Head and Neck Cancer; Local Recurrent Tumor

Outcome Measures

Primary Outcomes (1)

• Any unexpected severe adverse event resulting from the combination treatment.

  The investigators specify that the key feasibility objectives for our study would be considered successful if the following are met: 80% of patients received methylene blue experience no unpredicted harm during the treatment of methylene blue. The definition of unpredicted harm includes death within one month after last dose of methylene blue administration, or unpredicted ≧ grade 3 AE during methylene blue administration. The severity of adverse events was assessed using CTCAE v5.0.

  "through study completion, an average of 1 year"

Study Arms (1)

Methylene blue intratumoral injection combined with radiation

EXPERIMENTAL

Drug: Methylene Blue (50 mg/10ml)

Interventions

Methylene Blue (50 mg/10ml) DRUG

1. Methylene blue (50mg/10mL): Volume: 2 mL, 5 mL, 8 mL and 10mL are used for intratumoral injections in different lesion sizes. Frequency: weekly 2. Radiation dose: 50-60 Gy for target lesions

Methylene blue intratumoral injection combined with radiation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed squamous cell carcinoma of head and neck.
• Locoregional recurrence.
• After standard treatment of R/M HNSCC.
• Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI).
• Lesion selection criteria - at least 1 lesion to be injected must be measurable and greater than or equal to 1.5 cm and longest diameter not exceed 10 cm in principle.
• ECOG performance status ≤2.
• Age ≧20 years old; and life expectancy of at least 12 weeks.
• Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration.
• Must not have received anticancer therapy used with an antineoplastic intent, including chemotherapy, immunotherapy, biologic, or any investigational therapy within 14 days prior to the first dose of study drug.
• No history of allergic reactions attributed to methylene blue.
• Patient consent must be obtained.
• Negative pregnancy test, Fertile patients must use effective contraception.

You may not qualify if:

• Presence of central nervous system (CNS) metastases.
• The organ function measured within 14 days prior to study entry as defined below: Absolute neutrophil count (ANC) less than 1,000/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤40 ml/min.
• Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia.
• Documented hypersensitivity to methylene blue compound or compounds of similar chemical or biologic composition.
• Pregnant or lactating women.

Sponsors & Collaborators

• China Medical University Hospital: lead
• China Medical University, Taiwan: collaborator

Study Sites (1)

China medical university hospital

Taichung, Taiwan, 404, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: February 27, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)