High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors

Inclusion Criteria:

1. Patient is able to provide informed consent and sign approved consent forms to participate in the study.
2. Males ≥ 18 years of age at the time of signing the IC Form.
3. Histologically verified diagnosis of GO (seminomatous, non-seminomatous).

2\. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO.

3\. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP).

4\. Required Initial Laboratory Values:

* Hemoglobin ≥ 90 g/L;
* neutrophils ≥ 1.5 x 109/L;
* platelets ≥ 75 x 109/L;
* creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL/min);
* ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases);
* bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol/L);
* alkaline phosphatase ≥ 2.5 x IUH. 5. Absence of neurologic symptoms in the presence of CNS metastases (asymptomatic CNS metastases are acceptable).

Exclusion Criteria:

1. Primary CS of the brain
2. Administration of ≥2 lines of prior drug therapy for disseminated GO.
3. 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.
4. Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).