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Study of Hydroxychloroquine Effects in Patients with Resectable Head and Neck Cancer or Non-small Cell Lung Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on two types of cancer: Head and Neck cancer (specifically cancers of the mouth and voice box) and Non-small cell lung cancer. The research examines how a medication called hydroxychloroquine might affect cancer cells and their surrounding environment. This medication will be given to patients who are scheduled to have surgery to remove their cancer.

The study will investigate how hydroxychloroquine affects both the cancer cells and the immune system cells around the tumor. Patients will receive the medication before their planned surgery. The medication will be taken by mouth, with a maximum daily dose of 1200 mg and can be given for up to 15 days.

After the surgery, researchers will examine the removed tumor tissue to understand how the medication affected the cancer cells and the surrounding tissue. They will look for specific markers that show changes in the tumor cells and immune system responses. This will help determine if hydroxychloroquine could be beneficial as part of cancer treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial qualification
You will be evaluated to confirm if you have resectable head and neck cancer (squamous cell carcinoma of the oral cavity or larynx) or resectable non-small cell lung cancer (lung squamous cell carcinoma or adenocarcinoma).
Your doctor will check if your QTc interval (a heart rhythm measurement) is lower than 450 msec.
Your general health status will be evaluated using the ECOG scale (a measure of daily living abilities) which should be between 0-2.
Step 2
Medical examination
Your tumor will be measured and evaluated according to RECIST 1.1 criteria (standard way to measure tumor size).
If you have lung cancer, your PDL1 levels (a specific protein marker) must be above 50%.
Step 3
Treatment period
You will receive hydroxychloroquine orally before your scheduled surgery.
The medication effects will be studied on your tumor tissue after surgery.
Your tumor tissue will be examined for specific markers (CD3, CD8, CD163, p53, p62, LC3) to evaluate how the medication affected the cancer cells.
Step 4
Safety requirements
If you are able to have children, you must use effective contraception during the study.
Contraception must continue for 4 weeks after completing the medication.
The study period will run from September 2024 to September 2025.

Who can join the trial?

11 criteria

Must be at least 18 years old
Must have one of the following cancers:
- Head and neck cancer (squamous cell carcinoma of oral cavity or larynx) at stages I, II, III, or IV that can be surgically removed
- Non-small cell lung cancer (squamous cell carcinoma or adenocarcinoma) at stages IA, IB, IIA, or IIB that can be surgically removed
- Must not have received any previous treatment for the cancer
- Must have good physical function status (ECOG score between 0-2, which measures ability to care for oneself and daily activity level)
- Must be able to provide informed consent
- Must have a QTc interval (a heart rhythm measurement) less than 450 milliseconds
- Must have cancer that can be measured or evaluated using standard criteria (RECIST 1.1)
- For patients with lung cancer: must have PDL1 levels above 50% (a protein marker)
- For women who can become pregnant: must use effective birth control for at least 1 month before screening and continue throughout the study, plus 4 weeks after completing treatment
- For men who can father children: must use condoms or other effective birth control methods with partner during the study period

Who cannot join the trial?

15 criteria

Patients with non-resectable (inoperable) head and neck or lung cancer
Patients with cancer types other than:
- Squamous Cell Carcinoma of the oral cavity
- Squamous Cell Carcinoma of the larynx (voice box)
- Lung Squamous Cell Carcinoma
- Lung Adenocarcinoma (a type of lung cancer that starts in gland cells)
- Patients under 18 years of age
- Patients who are unable to provide informed consent
- Patients with known allergy or sensitivity to Hydroxychloroquine (the study medication)
- Patients who are currently participating in other clinical trials
- Patients with severe heart, liver, or kidney problems
- Patients with conditions that could interfere with the study medication, including:
  - Severe visual impairment
  - Blood disorders
  - Seizure disorders
  - Pregnant or breastfeeding women
  - Patients taking medications that could interact with Hydroxychloroquine

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Verified sites

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Verified
Ospedale San Raffaele S.r.l.
Milan, Italy

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Investigated drugs

Hydroxychloroquine is a medication that was originally developed to treat malaria but has also shown potential in cancer treatment. In this trial, it is being studied for its effects on cancer cells and their surrounding environment. The medication works by interfering with certain cellular processes that may help control tumor growth. It can affect how cancer cells interact with their environment and may help make cancer treatments more effective. The medication is being tested specifically in patients who have head and neck cancer or non-small cell lung cancer that can be surgically removed.

Hydroxychloroquine Sulfate

What is already known about the treatment

Hydroxychloroquine - A medication traditionally used to treat malaria that is administered orally in tablet form, now being investigated for potential anti-cancer properties in head and neck cancer and non-small cell lung cancer. It works at the molecular level by inhibiting autophagy, a cellular recycling process that cancer cells often use to survive, and may also affect the tumor microenvironment. This drug belongs to the class of antimalarial medications known as 4-aminoquinolines and has been well-documented in medical literature for its immunomodulatory effects, which has led to its investigation in various cancer clinical trials. In this specific trial, researchers are studying its potential therapeutic benefits for patients with resectable squamous cell carcinoma of the oral cavity, larynx, and certain types of lung cancer.

Investigated diseases

Head and Neck Squamous Cell Carcinoma
A cancer that develops in the cells lining the moist surfaces inside the head and neck region, specifically in the oral cavity and larynx. The disease begins when squamous cells start to grow uncontrollably and form tumors. These cancer cells can develop in the mouth, tongue, and voice box areas.
Non-small Cell Lung Cancer
A type of lung cancer that includes two main subtypes: squamous cell carcinoma and adenocarcinoma. The disease starts in the lung tissue, where abnormal cells begin to multiply and form tumors. Squamous cell type typically develops in the central part of the lungs, while adenocarcinoma usually occurs in the outer regions of the lungs.