Actively Recruiting
Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer.
Led by National Cancer Institute, Slovakia · Updated on 2025-08-13
33
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Germ cell tumors (GCTs) are highly curable malignancies; however, a subset of patients with relapsed or refractory disease after first- and second-line chemotherapy have a very poor prognosis, with long-term survival rates below 5%. New therapeutic strategies are needed in this setting. Emerging evidence indicates that extracellular DNA and markers of NETosis are associated with poor prognosis in GCTs, while DNase activity decreases with disease progression. Dornase alfa, a recombinant human DNase I approved for cystic fibrosis, may restore DNA homeostasis by degrading extracellular DNA. Preclinical studies demonstrated that dornase alfa, when combined with cisplatin, inhibited tumor growth in cisplatin-resistant GCT xenograft models. This proof-of-concept phase II study aims to evaluate the safety and efficacy of dornase alfa in combination with cisplatin in patients with relapsed or refractory GCTs, hypothesizing that extracellular DNA degradation by dornase alfa may enhance tumor control and restore cisplatin sensitivity.
CONDITIONS
Official Title
Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Adult men aged 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed extracranial primary germ cell cancer, seminoma, or non-seminoma
- Rising serum markers or biopsy-proven unresectable germ cell cancer
- Multiple relapsed or refractory germ cell tumors with at least 2 prior chemotherapy lines or relapse after high-dose chemotherapy
- Primary mediastinal germ cell tumors in first relapse
- Disease not curable by surgery or chemotherapy as judged by investigator
- Measurable disease according to RECIST 1.1
- Adequate blood cell counts: ANC > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 9 g/dl
- Adequate liver function: total bilirubin < 1.5 times upper limit normal, ALT and AST < 3 times upper limit normal or < 5 times if liver metastases present
- Adequate renal function with creatinine clearance > 50 ml/min
- At least 4 weeks since last chemotherapy or radiotherapy
- At least 4 weeks since last major surgery
- Complete recovery from prior surgery and previous therapy side effects to grade 1
- No psychological, familial, sociological, or geographical issues that could impair study compliance
- Male patients with female partners of childbearing potential agree to use effective contraception during study and for 6 months after last treatment
You will not qualify if you...
- Not meeting inclusion criteria
- Previous malignancy other than successfully treated nonmelanoma skin cancer
- Concurrent approved or investigational anticancer treatments including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy
- Female patients
- Severe acute or chronic medical conditions or lab abnormalities increasing risk or making patient unsuitable for study
- Known hypersensitivity to study drugs or related recombinant protein products
- Participation in another clinical trial involving drugs or medical products within last 30 days or 5 half-lives of investigational drug, whichever is longer
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Institute
Bratislava, Slovakia, 83101
Actively Recruiting
Research Team
M
Michal Mego, Prof, MD, DSc
CONTACT
D
Daniela Svetlovska, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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