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

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What is this study about?

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.

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.

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%.

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.

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 Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Ospedale San Raffaele S.r.l.	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Hydroxychloroquine Sulfate

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.

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.

Trial ID:

2024-516189-12-00

Protocol code:

HCQHNLcancer

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?