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Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer.

NCT07121322 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-08-13

No results posted yet for this study

Summary

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

  • Refractory Germ Cell Tumors
  • Dornase Alfa

Interventions

DRUG

dornase alfa i.v. and cisplatin

Cisplatin 100mg/m2 day 1, every 3 weeks, Dornase alfa 125 microgram/kg day 1-5 i.v. push over 30 seconds±5 seconds

Sponsors & Collaborators

  • National Cancer Institute, Slovakia

    lead OTHER_GOV

Principal Investigators

  • Michal Mego, prof. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2027-07-30
Completion
2028-07-30

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121322 on ClinicalTrials.gov