RecruitingPhase 2NCT06418789

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

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Enrollment

25 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Germ Cell Tumor

Summary

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria13

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).
\. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO.
\. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP).
\. 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 Criteria4

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).

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Interventions

DRUGHigh-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )

TI: Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest. Leukapheresis will be performed starting on day 11 in case blood level of CD45+CD34+ above 20x10\^6/L is achieved. CE: Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m\^2 IV daily days -4 to -2, autlologous stemm cell transplantation \>=2\*10\^6/Kg at day 0, GCSF support from day 4 until the recovery of neutrophils above 1\*10\^9/L. Patients will receive two cycles of TI followed by 3 cycles of CE in case at least 6\*10\^6 CD34+ stem cells will be harvested.