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Completed

NCT Number: NCT03042429

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

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).

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Key information

Conditions

Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

6 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Cologne

Cologne, 50924, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cycles N8, N5 and N6

Drug

two chemotherapy cycles N8 followed by standard arm therapy

Other names: topotecan, cyclophosphamide, etoposide

Cycles N5 and N6

Drug

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

Primary outcomes

  1. Event free survival

    Time frame: up to 9 years

    days from diagnosis to Event or last follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Acronym: NB2004-HR

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2017
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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