AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II study of dornase alpha and cisplatin in refractory germ cell cancer.

This research study is investigating a new treatment approach for men with germ cell cancer where previous treatments haven't worked well. It's a Phase II study, meaning researchers are carefully looking at how effective and safe this new combination treatment is. The treatment involves giving a common chemotherapy drug called cisplatin alongside another medicine known as Pulmozyme. The main goal is to see if this combination can prevent the cancer from getting worse for at least 12 weeks. Researchers will also be checking how many people respond to the treatment, how long they live, and any side effects they might experience. This study is for adult men aged 18 and over.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Narodny Onkologicky Ustav

Enrolment target

Start

09 Jul 2025

germ cell cancer

What is this study about?

This study is about finding better ways to treat germ cell cancer, especially when the cancer has returned or hasn't responded to standard treatments. Germ cell cancer can start in different parts of the body, but it's often found in the testicles. When these cancers become 'refractory' it means they are difficult to treat with usual methods, so new options are really important.

The researchers want to see if combining two existing medicines – cisplatin and Pulmozyme – could offer a new hope. Cisplatin is a type of chemotherapy that is often used to treat various cancers, including germ cell tumours. Pulmozyme (also known as dornase alpha) is a medicine that helps to break down thick mucus, and it's thought it might also help other cancer treatments work better.

By combining these two drugs, doctors hope to make the treatment more effective at stopping the cancer from growing. They will be carefully watching to see if the cancer stays stable or shrinks, and if people experience fewer side effects than expected. This kind of research helps doctors understand if a new treatment combination is promising enough to be studied in even larger groups of people later on.

Key takeaways

This study explores a new combination for hard-to-treat germ cell cancer.
It combines standard chemotherapy (cisplatin) with Pulmozyme.
The main goal is to see if the cancer stops growing for at least 12 weeks.
It's open to adult men (18+) whose cancer hasn't responded to previous treatments.
Participation involves regular treatments, tests, and follow-up care.

Who may be eligible?

To be able to join this study, you would need to be an adult man, aged 18 or older. There is no upper age limit for participation.

The study is specifically designed for men who have germ cell cancer that hasn't responded well to previous treatments, or if the cancer has come back after treatment. This is an important point because the study is trying to find new options for these difficult-to-treat situations.

Beyond age and cancer type, doctors will also check other things about your health to make sure that taking part in the study would be safe for you. This often includes looking at your general health, how well your organs are working, and any other medical conditions you might have.

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 an adult man (18 years or older)?
Have you been diagnosed with germ cell cancer?
Has your germ cell cancer either not responded to previous treatments or come back after treatment?
Are you generally well enough to undergo cancer treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a course of treatment over a period of time. You would receive both cisplatin and Pulmozyme according to a specific schedule prepared by the doctors. This will likely involve regular hospital visits for treatments and check-ups.

Throughout the study, you would have regular medical assessments, which might include blood tests, scans (like CT scans or MRI scans) to see how the cancer is responding, and physical examinations. These tests are important for understanding if the treatment is working and to monitor any side effects. Researchers will be particularly interested in whether your cancer stops growing for at least 12 weeks.

After the initial treatment phase, there will be follow-up appointments to continue monitoring your health and the status of your cancer. The total duration of your participation, including follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Participating in a study like this might offer a potential benefit: the possibility that this new combination treatment could help control your cancer where other treatments haven't. However, there's no guarantee the treatment will work for you, and it might not be better than existing options. There are also potential risks involved, as all medications can have side effects. Both cisplatin and Pulmozyme have known side effects, some of which can be serious, and the study will carefully monitor these. You will be fully informed of all known and potential risks before you decide to take part. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Slovakia

Common questions

What is germ cell cancer?

Germ cell cancer is a type of cancer that starts in the cells that produce sperm or eggs. While it often begins in the testicles or ovaries, it can sometimes start in other parts of the body.

What does 'refractory' mean in this study?

'Refractory' means that the cancer has not responded to previous treatments or has come back after earlier treatments. This study is looking for new options for these hard-to-treat situations.

What kind of medicines are being used?

The study uses two medicines: cisplatin, which is a common chemotherapy drug, and Pulmozyme (dornase alpha), which is used for other conditions but is being tested here to see if it helps cisplatin work better against cancer.

What is a 'Phase II' study?

A Phase II study is a stage of clinical research where doctors look closely at how safe and effective a new treatment or treatment combination is for a specific condition. It's a step before larger studies.

Will I have to pay to be in the study?

No, you will not have to pay for the study medications or any of the tests and procedures that are directly related to the research. These costs are covered by the study.