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

Neuroblastoma Clinical Trial

— NB2004-HR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042429
• Other study ID #: UCologne
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2017
• Last updated: February 3, 2017
• Start date: January 1, 2007
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• Cycles N8, N5 and N6
two chemotherapy cycles N8 followed by standard arm therapy
• Cycles N5 and N6
Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin

Locations

Country	Name	City	State
Germany	University of Cologne	Koln

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Berthold F, Boos J, Burdach S, Erttmann R, Henze G, Hermann J, Klingebiel T, Kremens B, Schilling FH, Schrappe M, Simon T, Hero B. Myeloablative megatherapy with autologous stem-cell rescue versus oral maintenance chemotherapy as consolidation treatment i — View Citation

Berthold F, Hero B, Kremens B, Handgretinger R, Henze G, Schilling FH, Schrappe M, Simon T, Spix C. Long-term results and risk profiles of patients in five consecutive trials (1979-1997) with stage 4 neuroblastoma over 1 year of age. Cancer Lett. 2003 Jul — View Citation

Berthold F, Hero B. Neuroblastoma: current drug therapy recommendations as part of the total treatment approach. Drugs. 2000 Jun;59(6):1261-77. Review. — View Citation

Längler A, Christaras A, Abshagen K, Krauth K, Hero B, Berthold F. Topotecan in the treatment of refractory neuroblastoma and other malignant tumors in childhood - a phase-II-study. Klin Padiatr. 2002 Jul-Aug;214(4):153-6. — View Citation

Outcome

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