Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorNational Cancer Institute, Slovakia
About this trial
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.
Eligibility criteria
Qualifiers
Signed written informed consent.
Adult men aged 18 years or older.
ECOG (Eastern Cooperative Oncology Group) performance status: 0-1.
Histologically confirmed extracranial primary germ cell cancer, seminoma, or non-seminoma.
Disqualifiers
Patients who do not fit inclusion criteria.
Other prior malignancy except successfully treated nonmelanoma skin cancer .
Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy.
Female patients.
Trial design
Treatments tested in this trial
- dornase alfa i.v. and cisplatin
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov