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Study of dornase alfa and cisplatin treatment for patients with refractory germ cell cancer

Registered drug

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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 treating germ cell cancer, a type of cancer that begins in the cells that produce eggs or sperm. The research examines a combination of two medications: dornase alfa, an enzyme that breaks down certain types of DNA, and cisplatin, a commonly used chemotherapy drug. This treatment approach is being studied in patients whose cancer has returned or has not responded to previous treatments.

The study aims to determine if this combination of medications can help prevent the cancer from growing or spreading in patients who have already undergone at least two previous rounds of chemotherapy. The treatment will be given through intravenous administration and will continue for up to 24 months, depending on how well patients respond to the therapy.

During the study, patients will receive regular doses of both medications. Cisplatin will be given at doses up to 100 milligrams per square meter of body surface area, while dornase alfa will be administered at doses up to 125 micrograms per kilogram of body weight. The effectiveness of this treatment will be evaluated primarily by measuring how long patients remain without their disease getting worse.

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 treatment cycle
Your treatment will involve two medications: cisplatin given through an infusion into a vein, and dornase alfa (Pulmozyme) administered directly into your bloodstream
Before starting treatment, your doctor will check your blood counts, liver function, and kidney function to ensure it's safe to proceed
You must wait at least 4 weeks after any previous treatments (chemotherapy, radiation therapy, or surgery) before starting this treatment
Step 2
Regular monitoring
Your doctor will regularly check your blood markers, including substances called alfa-fetoprotein and human chorionic gonadotropin
Regular scans will be performed to measure how your tumors are responding to treatment
Your doctor will monitor you for any side effects and adjust treatment if needed
Step 3
Follow-up period
After completing treatment, you will need to continue using effective birth control methods for 6 months
Your doctor will continue monitoring your health and disease status for the duration of the study
The total study period is expected to last until May 2027
Step 4
Safety monitoring
Throughout the study, your doctor will track any side effects you experience
Regular blood tests will continue to monitor your blood counts, liver function, and kidney function
You should report any new symptoms or health concerns to your doctor immediately

Who can join the trial?

15 criteria

Must be a male aged 18 or older
Must have signed written informed consent
Must have confirmed germ cell cancer that has returned after at least 2 previous treatments
Must have adequate blood cell counts: - White blood cells above 1500/mm3 - Platelets above 100,000/mm3 - Hemoglobin above 9g/dl
Must have proper liver function as shown by blood tests
Must have proper kidney function with creatinine clearance above 50 ml/min
Must wait at least 4 weeks after last chemotherapy or radiation therapy
Must wait at least 4 weeks after any major surgery
Must have recovered from previous treatments with minimal side effects
Must be able to perform daily activities with minimal or no assistance (ECOG status 0-1)
Must have measurable disease according to RECIST 1.1 criteria (a standard way to measure tumors)
Must have either: - Rising tumor markers in blood tests - Cancer confirmed by tissue sample that cannot be removed by surgery
Must use effective contraception (condom) during the study and for 6 months after
Must be able to follow study requirements and attend follow-up visits
Female partners of childbearing age must also use effective contraception

Who cannot join the trial?

12 criteria

Male patients younger than 18 years old cannot participate
Female patients cannot participate in this trial
Patients who have not been previously diagnosed with germ cell cancer
Patients who have not received prior treatment for their cancer
Patients who have not experienced a relapse (return) of their cancer after previous treatment
Patients who currently participate in other clinical trials
Patients who are unable to understand and sign the informed consent form
Patients with serious heart, liver, or kidney problems that could interfere with the study treatment
Patients with active infections that require treatment
Patients who are allergic to cisplatin (chemotherapy medication) or dornase alfa (study medication)
Patients with other types of cancer besides germ cell tumors
Patients who are unable to follow the study schedule and requirements

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Investigated drugs

Dornase alfa
is a medication that helps break down DNA released from damaged cells. In cancer treatment, it may help make cancer cells more sensitive to other treatments. It is commonly used in cystic fibrosis patients to help thin mucus, but in this trial, it is being studied for its potential role in treating germ cell tumors.
Cisplatin
is a widely used chemotherapy medication that works by damaging the DNA of cancer cells, preventing them from dividing and growing. It is particularly effective in treating various types of cancers, including germ cell tumors. It has been a standard treatment for testicular cancer and other germ cell tumors for many years.

What is already known about the treatment

Dornase alfa
A synthetic version of human DNase I enzyme, administered through inhalation or injection, which helps break down DNA in thick secretions. This medication works by cutting apart the DNA strands in mucus, making it thinner and easier to clear, and is primarily used in treating cystic fibrosis and other respiratory conditions. It belongs to the class of mucolytic agents and works by targeting extracellular DNA that contributes to mucus viscosity.
Cisplatin
An intravenously administered platinum-based chemotherapy drug that is widely used in the treatment of various cancers, including germ cell tumors. This medication works by binding to DNA and causing cross-linking of DNA strands, which prevents cancer cells from dividing and leads to cell death. It belongs to the platinum-containing antineoplastic drug class and is considered one of the most effective chemotherapy agents, though it requires careful monitoring due to potential side effects on kidneys and hearing.

Investigated diseases

Germ Cell Cancer - A type of cancer that begins in the cells that produce eggs or sperm, typically developing in the testicles or ovaries. These cancers can occur in both children and adults, though they are most common in young adults. The disease can develop as seminomas or non-seminomas, with different growth patterns and characteristics. Germ cell cancers can grow and spread to other parts of the body through the blood or lymph system. These tumors often develop rather quickly and can affect multiple organs if not addressed.