NCT03042429

Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients

Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

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 (i.e., 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 (PCP/fungal prophylaxis, transfusions, antibiotics, G-CSF)

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Cycles N8, N5 and N6	two chemotherapy cycles N8 followed by standard arm therapy
DRUG	Cycles N5 and N6	Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin

Timeline

• Start date: 2007-01-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2017-02-03
• Last updated: 2017-02-06

Locations

1 site across 1 country: Germany