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

Phase 3

Completed

• Conditions: Neuroblastoma
• Interventions: Drug: Cycles N8, N5 and N6; Drug: Cycles N5 and N6

• Registration Number: NCT03042429
• Lead Sponsor: University of Cologne

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 (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)

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• neuroblastoma
• stage 4 neuroblastoma and age ≥1 - 21 years or MYCN amplification and age ≥6 months - 21 years
• informed consent obtained

Exclusion Criteria

• Participation in other trials
• Pregnancy, lactation, or insufficient contraception for girls in childbearing age,
• Any concomitant non-protocol anticancer therapy,
• Incomplete initial staging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
experimental arm	Cycles N8, N5 and N6	Drug: Cycles N8, N5, and N6 Drug: topotecan, cyclophosphamide, and etoposide (N8 cycle) followed by Drug: cisplatin, etoposide, and vindesine (N5 cycle) and Drug: vincristine, dacarbacine, ifosfamide, and doxorubicine (N6 cycle) followed by myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) and by 9 x retinoic acid cycles (6 months, 3 months break, 3 months)
standard arm	Cycles N5 and N6	Drug: Cycles N5 and N6 Drug: cisplatin, etoposide, and vindesine (N5 cycle) and Drug: vincristine, dacarbacine, ifosfamide, and doxorubicine (N6 cycle) followed by myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) and by 9 x retinoic acid cycles (6 months, 3 months break, 3 months)

Primary Outcome Measures

Name	Time	Method
Event free survival	up to 9 years	days from diagnosis to Event or last follow-up

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 9 years	days from diagnosis to death or last follow-up
late response	up to 9 months	remission status (INRG) measured before stem cell transplant
early response	up to 3 months	remission status (INRG) measured after 2 chemotherapy cycles

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Koln, Germany