Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year
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 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. A bone marrow transplant, using bone marrow from the patient, may be able to replace blood-forming cells that were destroyed by chemotherapy. It is not yet know which combination chemotherapy schedule is more effective, when given before surgery and an autologous bone marrow transplant, in treating patients with disseminated neuroblastoma.

PURPOSE: This randomized phase III trial is studying two different chemotherapy schedules to compare how well they work in treating young patients who are undergoing surgery and an autologous bone marrow transplant for disseminated neuroblastoma.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:

  * Age greater than 18 months with stage IV disease, regardless of biologic factors
  * Age 12-18 months with stage IV disease meeting one of the following criteria:

    * Any unfavorable biologic feature (e.g., MYCN amplification, unfavorable pathology, and/or DNA index = 1)
    * Any biologic feature that is indeterminate, unsatisfactory, or unknown
* At least 1 year old with the following:

  * Stage IIa/IIb with MYCN amplification (\> 10) AND unfavorable pathology
  * Stage III with MYCN amplification (\> 10) OR unfavorable pathology
  * Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy

    * No more than 3 weeks since progression
    * Must have been enrolled on protocol CCG-B973, COG-ANBL00B1, or POG-9047
* Less than 1 year old with the following:

  * Stage III, IV, or IVS disease with MYCN amplification (\> 10)
* Registration on protocol COG-ANBL00B1 required within 14 days of diagnosis

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics
* 30 and under at time of diagnosis

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Inadequate hematopoiesis secondary to bone marrow involvement with \> 10% tumor infiltration allowed

Hepatic:

* Bilirubin ≤ 1.5 mg/dL
* ALT ≤ 300 units/L

Renal:

* Creatinine ≤ 1.5 mg/dL
* Creatinine clearance or glomerular filtration rate ≥ 60 mL/min

Cardiovascular:

* ECG normal
* Ejection fraction ≥ 55% by echocardiogram or MUGA OR
* Fractional shortening ≥ 28% by echocardiogram

Other:

* Able to tolerate peripheral blood stem cell collection
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for at least 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* No more than 1 prior course of chemotherapy on the Intergroup low/intermediate risk neuroblastoma study (P9641, A3961)

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior localized emergency radiotherapy to sites of life-threatening or function-threatening disease allowed

Surgery:

* Not specified

Other

* No other prior systemic therapy
B: Inclusion Criteria:

* • Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS).

  * Age below 21 years.
  * High risk neuroblastoma defined as either:

    1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or
    2. INSS stage 4 without MYCN amplification aged \> 12 months at diagnosis
  * Patients who have received no previous chemotherapy except for one cycle of etoposide and carboplatin (VP16/Carbo). In this situation patients will receive Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the first cycle VP16/Carbo (etoposide / carboplatin).
  * Written informed consent, including agreement of parents or legal guardian for minors, to enter a randomised study if the criteria for randomisation are met.
  * Tumour cell material available for determination of biological prognostic factors.
  * Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
  * Registration of all eligibility criteria with the data centre within 6 weeks from diagnosis.
  * Provisional follow up of 5 years.
  * National and local ethical committee approval.

Exclusion Criteria:

Any negative answer concerning the inclusion criteria of the study

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C: DISEASE CHARACTERISTICS:

* Histologically confirmed disseminated neuroblastoma

  * No local or regional neuroblastoma
  * No disseminated disease that is demonstrated by meta-iodobenzylguanidine (MIBG) scan only
* Needle biopsy of primary tumor required

  * Fine needle aspiration is not adequate

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No other prior therapy
D: DISEASE CHARACTERISTICS:

* Histologically confirmed neuroblastoma
* Observation stratum:

  * MYCN gene not amplified
  * Infants with stage I-IVS disease OR
  * Over 1 year of age and stage I or II resectable disease
* Standard-risk stratum:

  * MYCN gene not amplified
  * Infants with serious symptoms and stage II-IVS disease OR
  * Over 1 year of age with stage II or III unresectable disease
* High-risk stratum:

  * Stage IV disease OR
  * Stage I-IVS MYCN gene-amplified disease

PATIENT CHARACTERISTICS:

Age:

* 20 and under

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* No kidney insufficiency

Cardiovascular:

* No cardiac insufficiency

Other:

* Not pregnant
* Fertile patients must use effective contraception
* No other serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy within 6 months after diagnosis

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Answer: C