Clinical trial · Interventional

Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma Who Are Undergoing Surgery With or Without Autologous Bone Marrow or Peripheral Stem Cell Transplant

European Infant Neuroblastoma Study Final Protocol

NCT00417053CI-TRIAL-00011530unknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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 more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. 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 which combination chemotherapy regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed neuroblastoma. PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, works in treating infants with newly diagnosed neuroblastoma.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (13)

Intervention	Type	Mapped drug	Match
autologous bone marrow transplantation	Procedure	—	UNRESOLVED
bone marrow ablation with stem cell support	Procedure	—	UNRESOLVED
busulfan	Drug	Busulfan	ALIAS
carboplatin	Drug	Carboplatin	ALIAS
conventional surgery	Procedure	—	UNRESOLVED
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
etoposide phosphate	Drug	Etoposide	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 1 Year

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed neuroblastoma or ganglioblastoma

  * Newly diagnosed disease
* MYCN status known
* Patients are assigned to different study treatment regimens\* according to the following disease criteria:

  * Regimen NB 99.1

    * Localized unresectable tumor

      * If open surgery is considered too hazardous due to the site of the tumor or condition of the infant, then cytological confirmation is allowed, provided adequate material is obtained for study procedures
    * No MYCN amplification (i.e., \< 10 copies)
    * No metastatic deposits in the bone marrow
    * No MIBG or technetium uptake or radiological bone lesions in the skeleton
    * No liver disease by ultrasound
  * Regimen NB 99.2

    * Stage 4 or 4S with metastases confined to the skin, marrow, nodes, or liver

      * No bone involvement by radiographs
      * No pleural or lung involvement
      * No CNS involvement
    * No MYCN amplification (i.e., \< 10 copies)
  * Regimen NB 99.3

    * Stage 4 disease, metastases must meet ≥ 1 of the following criteria:

      * Skeletal bone metastases by plain x-ray or CT scan
      * Pleural or lung metastases
      * CNS involvement
    * No MYCN amplification (i.e., \< 10 copies)
  * Regimen NB 99.4

    * Stage 2-4 disease
    * MYCN amplification (i.e., ≥ 10 copies) NOTE: \*Patients with stage 1 or resectable stage 2 disease with no MYCN amplification ( i.e., \< 10 copies) are not eligible for a study treatment regimen but may be enrolled on the study for observation only

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior therapy

References

Publications (0)

Data not yet available

No reference posted for this study.