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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03042429

Acronym

NB2004-HR

Enrollment

360

Registered

2017-02-03

Start date

2007-01-01

Completion date

2016-12-31

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

neuroblastoma, chemotherapy, autologous stem cell transplantation, radiotherapy, mIBG, tumor resection

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)

Interventions

DRUGCycles N8, N5 and N6

two chemotherapy cycles N8 followed by standard arm therapy

DRUGCycles N5 and N6

Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Masking description

no masking

Intervention model description

Randomized, multi-center, non-blinded, prospective, controlled trial

Eligibility

Sex/Gender

ALL

Age

6 Months to 21 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Event free survival	up to 9 years	days from diagnosis to Event or last follow-up

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026