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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042429
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Frank Berthold, University of Cologne

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date February 6, 2017
Actual Study Start Date  ICMJE January 1, 2007
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
Event free survival [ Time Frame: up to 9 years ]
days from diagnosis to Event or last follow-up
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
Event free survival [ Time Frame: up to 9 years ]
time from diagnosis to Event or last follow-up
Change History Complete list of historical versions of study NCT03042429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
  • Overall survival [ Time Frame: up to 9 years ]
    days from diagnosis to death or last follow-up
  • early response [ Time Frame: up to 3 months ]
    remission status (INRG) measured after 2 chemotherapy cycles
  • late response [ Time Frame: up to 9 months ]
    remission status (INRG) measured before stem cell transplant
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • Overall survival [ Time Frame: up to 9 years ]
    time from diagnosis to death or last follow-up
  • early response [ Time Frame: up to 3 months ]
    early response measured after 2 chemotherapy cycles
  • late response [ Time Frame: up to 9 months ]
    late response measured before stem cell transplant
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients
Official Title  ICMJE Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Randomized, multi-center, non-blinded, prospective, controlled trial
Masking: None (Open Label)
Masking Description:
no masking
Primary Purpose: Treatment
Condition  ICMJE Neuroblastoma
Intervention  ICMJE
  • Drug: Cycles N8, N5 and N6
    two chemotherapy cycles N8 followed by standard arm therapy
    Other Name: topotecan, cyclophosphamide, etoposide
  • 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 Name: cisplatin, vindesine, ifosfamide, dacarbacine, doxorubicine
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Cycles N8, N5 and N6
  • 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)
    Intervention: Drug: Cycles N5 and N6
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2017)
360
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03042429
Other Study ID Numbers  ICMJE UCologne
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Frank Berthold, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Frank Berthold, Prof. University of Cologne
PRS Account University of Cologne
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP