Purpose

This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Category

IRB Number
20130341HU
NCT Number
NCT01798004
Open to Enrollment
Yes
Sponsor
Children's Oncology Group -



Study Contact

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu



Eligibility

Eligible Ages
Under30 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      N/A
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Disseminated Neuroblastoma
    2. Localized Resectable Neuroblastoma
    3. Localized Unresectable Neuroblastoma
    4. Regional Neuroblastoma
    5. Stage 4S Neuroblastoma

      6. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (induction therapy, consolidation therapy, ASCT)

      		INDUCTION THERAPY: COURSES 1-2: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for 2 courses. COURSES 3 AND 5: Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide IV over 1-2 hours on days 1-3. Treatment repeats every 3 weeks for 2 courses. COURSE 4: Patients receive cyclophosphamide IV over 1-6 hours on days 1-2, vincristine sulfate IV over 1 minute on days 1-3, and doxorubicin hydrochloride IV over 24 hours on days 1-3. Treatment repeats every 3 weeks for 1 course. Treatment continues in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Beginning 4-8 weeks following the 5th course of induction therapy, patients receive busulfan IV over 3 hours on days -6 to -3 and melphalan IV on day -1. Patients undergo ASCT on day 0. Some patients also undergo EBRT after induction and consolidation.
    6. Drug: topotecan hydrochloride

      Given IV

      Other names:

      • hycamptamine
      • Hycamtin
      • SKF S-104864-A
      • TOPO

    7. Drug: etoposide

      Given IV

      Other names:

      • EPEG
      • VP-16
      • VP-16-213

    8. Drug: doxorubicin hydrochloride

      Given IV

      Other names:

      • ADM
      • ADR
      • Adria

    9. Drug: busulfan

      Given IV

      Other names:

      • BSF
      • BU
      • Misulfan
      • Mitosan
      • Myeloleukon

    10. Procedure: autologous hematopoietic stem cell transplantation

      Undergo autologous peripheral blood stem cell transplant

    11. Other: pharmacological study

      Correlative studies

      Other names:

      • pharmacological studies

    12. Biological: filgrastim

      Given SC or IV

      Other names:

      • G-CSF
      • Neupogen

    13. Drug: cyclophosphamide

      Given IV

      Other names:

      • CPM
      • CTX
      • Cytoxan
      • Endoxan
      • Endoxana

    14. Drug: cisplatin

      Given IV

      Other names:

      • CACP
      • CDDP
      • CPDD
      • DDP

    15. Drug: vincristine sulfate

      Given IV

      Other names:

      • leurocristine sulfate
      • VCR
      • Vincasar PFS

    16. Radiation: external beam radiation therapy

      Undergo EBRT

      Other names:

      • EBRT

    17. Drug: melphalan

      Given IV

      Other names:

      • Alkeran
      • CB-3025
      • L-PAM
      • L-phenylalanine mustard
      • L-Sarcolysin

    18. Procedure: peripheral blood stem cell transplantation

      Undergo autologous peripheral blood stem cell transplant

      Other names:

      • PBPC transplantation
      • PBSC transplantation
      • peripheral blood progenitor cell transplantation
      • transplantation, peripheral blood stem cell

    19. Other: laboratory biomarker analysis

      Optional correlative studies

    20. Drug: mesna

      Given IV

      Other names:

      • mercaptoethane sulfonate
      • Mesnex
      • MSA

      21.