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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
dornase alfa i.v. and cisplatin
DrugCisplatin 100mg/m2 day 1, every 3 weeks, Dornase alfa 125 microgram/kg day 1-5 i.v. push over 30 seconds±5 seconds
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Dornase alfa and cisplatinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12-week progresion-free survival
12-week post-treatment initiation continuous progression-free survival rate will be summarized as counts and proportions with exact binomial 90% confidence interval (ITT population)
Time frame
From enrollment to the end of treatment at 12 weeksSecondary outcomes
1
Overall response rate
Overall response rate (ORR) by RECIST 1.1 and tumor markers (AFP, HCG, LDH)
Time frame
From the treatment initiation till the first response assessment at week 62
Progression-free survival
From the start of treatment (day 1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time frame
From the start of treatment (day 1) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.3
Overall survival
Overall survival (OS) will be calculated from the start of treatment (day 1) until death from any cause assessed up to 100 months
Time frame
Overall survival (OS) will be calculated from the start of treatment (day 1) until death from any cause assessed up to 100 months.4
Frequency of treatment related adverse events
Treatment related adverse reaction according to common toxicity criteria
Time frame
From baseline through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov