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RECRUITING
NCT06418789
PHASE2

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

Sponsor: N.N. Petrov National Medical Research Center of Oncology

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-03-01

Completion Date

2029-03-01

Last Updated

2025-08-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

High-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.

Locations (1)

National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia

Saint Petersburg, Russian Federation, Russia