About this trial
This is a prospective, single-center, non-randomized phase II study. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy as second-line drug therapy for patients with advanced germ cell tumors.
Eligibility criteria
Qualifiers
Patient is able to provide informed consent and sign approved consent forms to participate in the study.
Males ≥ 18 years of age at the time of signing the IC Form.
Histologically verified diagnosis of GO (seminomatous, non-seminomatous).
Hemoglobin ≥ 90 g/L;
Disqualifiers
Primary CS of the brain
Administration of ≥2 lines of prior drug therapy for disseminated GO.
Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days prior to study inclusion.
Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).
Trial design
Treatments tested in this trial
- High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )