Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418789
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-08
Brief Title:
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Sponsor:
NN Petrov National Medical Research Center of Oncology
Organization:
NN Petrov National Medical Research Center of Oncology
Study Overview
Official Title:
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GERMAN
Brief 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
Detailed Description:
Germ cell tumors are curable diseases Only a small proportion of patients fail to be cured those who experience a primary resistance to chemotherapy and those who relapsed after first line conventional dose cisplatin-based chemotherapy Nowadays there is heterogeneity of practice in salvage approaches This includes conventional chemotherapy high dose chemotherapy with autologous stem cell transplant Best choice of the therapy strategy is an unmet clinical need now This is why this single-center non-randomized phase II study will be conducted at the NN Petrov National Medical Research Center of Oncology Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive two cycles of high-dose TI Paclitaxel 200mgm² on day 1 Ifosfamide 2000mgm² daily from days 1 to 3 of 14-day cycle G-CSF 10 microgramsKg SC daily day on days 6-14 day or until CD34 harvest leukapheresis will be performed starting on day 11 in case of CD45CD34 blood level above 20x106L is achieved followed by three cycles of high dose CE Carboplatin AUC8 IV daily days -4 to -2 Etoposide 400mgm2 IV daily days -4 to -2 autlologous stem cell transplantation at day 0 GCSF support from day 4 The primary endpoint of the study is to evaluate the efficacy by measuring progression-free survival The secondary endpoints of the trial are overall survival response rate by RECIST safety and prognostic factors analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None