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

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

March 1, 2029

Study Completion Date

March 1, 2029

Conditions
Germ Cell Tumor
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."

Trial Locations (1)

197758

RECRUITING

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

All Listed Sponsors
lead

N.N. Petrov National Medical Research Center of Oncology

OTHER