Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients (NB2004-HR)

February 3, 2017 updated by: Frank Berthold, University of Cologne

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Koln, Germany, 50924
        • University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
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)
Drug: Cycles N8, N5 and N6
two chemotherapy cycles N8 followed by standard arm therapy
Other Names:
  • topotecan, cyclophosphamide, etoposide
Active Comparator: standard arm
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)
Drug: Cycles N5 and N6
Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin
Other Names:
  • cisplatin, vindesine, ifosfamide, dacarbacine, doxorubicine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Study Chair: Frank Berthold, Prof., University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCologne

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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