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Trial record 23 of 524 for:    "Neuroblastoma"

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

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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

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).

Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: Cycles N8, N5 and N6 Drug: Cycles N5 and N6 Phase 3

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  (Clinical Trial)
Actual Enrollment : 360 participants
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
Official Title: Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-risk Neuroblastoma
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

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 Name: 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 Name: cisplatin, vindesine, ifosfamide, dacarbacine, doxorubicine




Primary Outcome Measures :
  1. Event free survival [ Time Frame: up to 9 years ]
    days from diagnosis to Event or last follow-up


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 9 years ]
    days from diagnosis to death or last follow-up

  2. early response [ Time Frame: up to 3 months ]
    remission status (INRG) measured after 2 chemotherapy cycles

  3. late response [ Time Frame: up to 9 months ]
    remission status (INRG) measured before stem cell transplant



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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042429


Locations
Germany
University of Cologne
Koln, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Study Chair: Frank Berthold, Prof. University of Cologne

Publications of Results:
Responsible Party: Frank Berthold, Prof. Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT03042429     History of Changes
Other Study ID Numbers: UCologne
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frank Berthold, University of Cologne:
neuroblastoma
chemotherapy
autologous stem cell transplantation
radiotherapy
mIBG
tumor resection

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Liposomal doxorubicin
Etoposide phosphate
Isophosphamide mustard
Cisplatin
Cyclophosphamide
Doxorubicin
Etoposide
Topotecan
Ifosfamide
Vindesine
Isotretinoin
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists