Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer.
Sponsor: National Cancer Institute, Slovakia • ClinicalTrials.gov ID: NCT07121322
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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.
Interventions
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dornase alfa i.v. and cisplatin
(Drug)
Cisplatin 100mg/m2 day 1, every 3 weeks, Dornase alfa 125 microgram/kg day 1-5 i.v. push over 30 seconds±5 seconds
Eligibility criteria
Conditions
Locations
- National Cancer Institute — Bratislava, Slovakia
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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