Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancer

This research is investigating if a medicine called hydroxychloroquine, normally used for other conditions, could be helpful in treating specific types of head and neck cancer (squamous cell carcinoma of the mouth or voice box) and certain lung cancers (non-small cell lung cancer, including squamous cell carcinoma or adenocarcinoma). The study aims to understand how hydroxychloroquine affects cancer cells at a biological level. Researchers will look at changes in the cancer tissue, like certain markers and how the body's immune cells react. This is an early stage (Phase II) study to explore its potential, not to confirm it as a standard treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ospedale San Raffaele S.r.l.

Enrolment target

Start

29 Jul 2024

Patients affected by Resectable Head and Neck (HN) cancer (only Squamous Cell Carcinoma of the oral cavity or larynx)or Resectable Non-small cell lung cancer (NSCLC only Lung Squamous Cell Carcinoma or Adenocarcinoma).

What is this study about?

This study is called a 'clinical trial', which means it's a carefully planned research study involving people. The main goal here is to explore if a medication called hydroxychloroquine (often known as HCQ) might play a helpful role in treating certain types of cancer.

Specifically, the researchers are interested in two main cancer groups: some head and neck cancers, and a common type of lung cancer. For head and neck cancer, they are focusing on mouth or voice box cancers called squamous cell carcinoma. For lung cancer, they are looking at a type called non-small cell lung cancer, which includes adenocarcinoma and squamous cell carcinoma. The study is for people whose cancer can be removed by surgery.

The main thing the scientists want to understand is how hydroxychloroquine affects the cancer cells. They will do this by looking closely at tissue samples from the cancer. They'll search for specific signs (markers) that show changes in the cancer cells and how the body's immune system might be responding. This will help them see if the drug is having an effect at a very detailed level.

Key takeaways

This study is testing an existing drug, hydroxychloroquine, for certain cancers.
It's for people with specific types of head and neck cancer or lung cancer that can be surgically removed.
The main aim is to understand how the drug affects cancer cells.
This is an early-stage (Phase II) study, exploring potential, not a guaranteed new treatment.
Participation would involve taking the drug and having tissue samples analysed.

Who may be eligible?

To take part in this study, you would need to be an adult, aged 18 or older – there’s no upper age limit. The study is open to both men and women.

You would also need to have been diagnosed with one of the specific types of cancer mentioned. This includes certain head and neck cancers that can be surgically removed, specifically squamous cell carcinoma of the mouth or voice box (larynx).

Alternatively, you could have a type of lung cancer called non-small cell lung cancer that can be surgically removed. This includes two specific kinds: lung squamous cell carcinoma or adenocarcinoma.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a head and neck cancer (specifically squamous cell carcinoma of the mouth or voice box) that can be removed by surgery?
OR do you have a lung cancer (specifically non-small cell lung cancer, either squamous cell carcinoma or adenocarcinoma) that can be removed by surgery?
Are you able to participate in a clinical study involving medication and tissue analysis?

Answer every question to see your result.

What does participation involve?

This part of the information isn't fully detailed in the brief summary. Generally, taking part in a clinical trial might involve regular visits to a clinic or hospital for check-ups, blood tests, and scans. You would be given the study drug, hydroxychloroquine, to take as prescribed. Researchers would also collect tissue samples, likely during or after your surgery for the cancer, to see how the drug has affected the cancer cells. You would be closely monitored throughout the study, and there would be a follow-up period after your main treatment. The exact duration of your participation would be explained by the study team.

Potential risks and benefits

Potential benefits of taking part in this study are that you would receive a new treatment that might help with your cancer, and you would contribute to scientific knowledge that could help future patients. However, as this is an early-stage study, we don't yet know if hydroxychloroquine will be an effective treatment for these cancers. There are also potential risks, as hydroxychloroquine can have side effects, which would be fully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is hydroxychloroquine?

Hydroxychloroquine is a medication that's usually used to treat conditions like malaria and some autoimmune diseases, such as lupus or rheumatoid arthritis.

What does 'resectable' mean?

Resectable means that the cancer can be removed by surgery.

What is a Phase II study?

A Phase II study is an early stage clinical trial that looks at whether a new treatment works and is safe. It's not yet trying to prove it's better than existing treatments.

Will this drug cure my cancer?

This study is exploratory, meaning it's too early to say if hydroxychloroquine will cure cancer. Researchers are trying to understand its effects on cancer cells.

Why are researchers looking at tissue samples?

By looking at tissue samples closely, scientists can see how the drug affects the cancer cells at a microscopic level, helping them understand if it's having the desired biological effect.