Dornase alfa plus cisplatin for refractory germ cell cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II, proof-of-concept trial gives intravenous dornase alfa together with cisplatin to men with measurable extracranial relapsed or refractory germ cell tumors after at least two prior lines of chemotherapy or relapse after high-dose therapy. The rationale is that extracellular DNA and NETosis markers rise with disease progression while DNase activity falls, and enzymatic cleavage of extracellular DNA may restore DNA homeostasis and improve chemotherapy effects. Preclinical cisplatin-resistant xenograft models showed tumor growth inhibition with the combination, and the study will monitor safety, RECIST 1.1 tumor responses, and biomarker changes. Treatment and follow-up occur at a single center with eligibility requiring ECOG 0–1 and adequate hematologic and liver function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent.
2. Adult men aged 18 years or older.
3. ECOG (Eastern Cooperative Oncology Group) performance status: 0-1.
4. Histologically confirmed extracranial primary germ cell cancer, seminoma, or non-seminoma.
5. Rising serum markers (i.e., alfa-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer.
6. Multiple relapsed/refractory GCTs (at least 2 lines of previous chemotherapy) and/or patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy.
7. Primary mediastinal GCTs in first relapse.
8. Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator.
9. RECIST 1.1 measurable disease.
10. Adequate hematologic function defined by ANC \> 1500/mm3, platelet count \> 100 000/mm3 and hemoglobin level \> 9g/dl.
11. Adequate liver function defined by a total bilirubin level \< 1.5 ULN, and ALT, AST \< 3 ULN or \< 5 in case of liver metastases. For subjects with Gilbert's syndrome bilirubin \> 1.5 × ULN is allowed if no symptoms of compromised liver function are present.
12. Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance \> 50 ml/min. Cockcroft formula: CLcr = \[(140-age) x weight (Kg)\]/\[72 x creat (mg/dl)\].
13. At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry.
14. At least 4 weeks must have elapsed since the last major surgery.
15. Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1.
16. Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
17. Male patients with a female partner of childbearing potential who agree to use an effective method of contraception (condom) and a highly effective method of contraception by their female partner during the study and 6 months after the last study treatment intake.

Exclusion Criteria:

1. Patients who do not fit inclusion criteria.
2. Other prior malignancy except successfully treated nonmelanoma skin cancer .
3. Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy.
4. Female patients.
5. Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with study treatment, or which, in judgment of the investigator, would make the patient inappropriate for entry into this study.
6. Hypersensitivity to any compound of the drugs, severe known allergies or intolerance to other recombinant protein products obtained from Chinese hamster ovary cells according to Investigatorś decision.
7. Known participation in another clinical trial investigating a drug and/or medical product in the last 30 days or 5 half-lives of the investigational drug and/or medicinal product (whichever is longer).

Where it's running

• National Cancer Institute
  Bratislava, Slovakia Recruiting

Study contacts

• Study coordinator: Michal Mego, Prof, MD, DSc
• Email: michal.mego@nou.sk
• Phone: 259378108

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.