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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
• Treatments: 3-Iodobenzylguanidine; Carboplatin; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isotretinoin; Liposomal doxorubicin; Melphalan; Topotecan; Vincristine; Vindesine

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