Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03042429
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2017-02-01
Brief Title:
Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2017-02
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:
NB2004-HR
Brief Summary:
Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment induction chemotherapy myeloablative therapy radiation surgery as indicated and consolidation therapy
Detailed Description:
Experimental intervention 6 weeks duration of the control intervention
2 x N8 cycle topotecan cyclophosphamide and etoposide followed by standard arm treatment ie control intervention
Control intervention total duration 70-76 weeks
3 x N5 cycle cisplatin etoposide and vindesine 3 x N6 cycle vincristine dacarbacine ifosfamide and doxorubicine myeloablative chemotherapy with autologous stem cell transplantation melphalan carboplatin etoposide 9 x retinoic acid cycles 6 months 3 months break 3 months supportive care PCPfungal prophylaxis transfusions antibiotics G-CSF
2 x N8 cycle topotecan cyclophosphamide and etoposide followed by standard arm treatment ie control intervention
Control intervention total duration 70-76 weeks
3 x N5 cycle cisplatin etoposide and vindesine 3 x N6 cycle vincristine dacarbacine ifosfamide and doxorubicine myeloablative chemotherapy with autologous stem cell transplantation melphalan carboplatin etoposide 9 x retinoic acid cycles 6 months 3 months break 3 months supportive care PCPfungal prophylaxis transfusions antibiotics G-CSF
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