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Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00410631
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : December 13, 2006
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether observation is more effective than combination chemotherapy, radiation therapy, and/or autologous stem cell transplant in treating neuroblastoma.

PURPOSE: This randomized phase III and phase IV trial is studying observation, combination chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well they work in treating young patients with neuroblastoma.


Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: ifosfamide Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Drug: vindesine Procedure: autologous hematopoietic stem cell transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: iobenguane I 131 Radiation: radiation therapy Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 642 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma
Study Start Date : October 2004
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Event-free survival (EFS)
  2. Locoregional EFS

Secondary Outcome Measures :
  1. Time from diagnosis to transition to stage 4 disease, to death from disease, or to the last follow-up (if no transition to stage 4 disease is observed)
  2. Overall survival
  3. Time to the beginning of primary tumor regression (in patients in the low-risk group [LRG])
  4. Time to the normalization of tumor markers HVA and VMA in urine
  5. Time to no evidence of disease (in patients in the LRG with stage 4S disease)
  6. Status of the primary tumor 12 months after diagnosis (LRG)
  7. Best status of the primary tumor within the first 12 months (LRG)
  8. Status of chromosome 1p (unblinded) and status of chromosome 11q (blinded)
  9. Comparison of the extent of initial surgery (incomplete resection vs macroscopic complete resection) (LRG)
  10. Comparison of the extent of best surgery during protocol treatment (incomplete resection vs macroscopic complete resection)
  11. Surgery-related complications (i.e., bleeding, infection, intestinal obstruction, or other)
  12. Disease progression and symptoms controlled after the first, second, third, and fourth N4 course (LRG)
  13. Disease progression and symptoms not controlled after four N4 courses (LRG)
  14. Transition to stage 4 disease at any time (LRG)
  15. Acute and late side effects of external-beam radiotherapy (medium-risk group [MRG] and high-risk group [HRG])
  16. Early response after 2 courses of induction therapy (N5 and N6 or two courses of N8) (HRG)
  17. Response to induction therapy prior to conditioning therapy or after 280 days (HRG)
  18. Grade of toxicity observed during induction therapy course 1 (N5 or N8) (HRG)
  19. Grade of toxicity observed during induction therapy course 2 (N6 or N8) (HRG)
  20. Frequency of grade 3 or 4 toxicity observed during the last 6 courses of induction therapy (3 courses of N5 and N6) (HRG)
  21. Activity and whole body dose of radiotherapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Diagnosis of neuroblastoma by histology using tumor tissue or as evidenced by the presence of distinct neuroblastoma cells in the bone marrow AND elevated catecholamine metabolites (i.e., homovanillic acid [HVA] and vanillylmandelic acid [VMA]) in blood or urine

    • Newly diagnosed disease (for patients in the low-risk group)
    • Diagnosis from tumor tissue (for patients in the medium-risk group)
  • Meets criteria for 1 of the following risk groups:

    • Low-risk group

      • No MYCN amplification AND meets 1 of the following criteria:

        • Stage 1 disease
        • Stage 2 disease with no chromosome 1p deletion or imbalance
        • Stage 3 disease with no chromosome 1p deletion or imbalance (for patients < 2 years of age)
        • Stage 4S disease (for patients < 1 year of age)
    • Medium-risk group

      • No MYCN amplification AND meets 1 of the following criteria:

        • Stage 2 disease with chromosome 1p deletion or imbalance
        • Stage 3 disease with chromosome 1p deletion or imbalance

          • Any chromosome 1p status (for patients ≥ 2 years of age)
        • Stage 4 disease (for patients < 1 year of age)
    • High-risk group, meeting 1 of the following criteria:

      • Any stage disease with MYCN amplification

        • Any MYCN status (for patients ≥ 1 year of age)

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior nephrectomy or other mutilating surgery as initial surgery (for patients in the low-risk group)
  • No other concurrent anticancer therapy
Contacts and Locations

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): NCT00410631


  Show 80 Study Locations
Sponsors and Collaborators
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Investigators
Study Chair: Frank Berthold, MD Children's Hospital Medical Center, Cincinnati
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00410631     History of Changes
Other Study ID Numbers: GPOH-NB2004
CDR0000517312 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20661
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: January 2008

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
disseminated neuroblastoma
recurrent neuroblastoma

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
Cyclophosphamide
Melphalan
Ifosfamide
Liposomal doxorubicin
Etoposide phosphate
Carboplatin
Doxorubicin
Etoposide
Vincristine
Topotecan
3-Iodobenzylguanidine
Vindesine
Isotretinoin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action