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About
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms for peripheral blood stem cell (PBSC) collection.
All patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 0 and 1, doxorubicin IV and vincristine IV continuously over 72 hours on days 0-2, and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 3 and continuing until blood counts recover for courses 1, 2, 4, and 6. Treatment alternates with courses 3 and 5 comprising etoposide IV over 2 hours on days 0-2, cisplatin IV over 1 hour on days 0-3, and G-CSF SC or IV beginning on day 4 and continuing until blood counts recover. Induction chemotherapy repeats every 3 weeks or when blood counts recover in the absence of disease progression or unacceptable toxicity.
After course 2 or 3 of induction chemotherapy, patients undergo PBSC collection, either purged or unpurged, depending on randomization. Patients continue on daily G-CSF until cell collection is complete.
Patients with immunocytology positive PBSC undergo purged autologous bone marrow collection or repeat purged or unpurged PBSC collection depending on individual patient characteristics.
All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy.
After induction therapy, patients achieving complete response, very good partial response, or partial response receive consolidation therapy comprising melphalan IV on days -7 to -5 followed by carboplatin IV and etoposide IV continuously over days -7 to -4. Patients receive purged or unpurged PBSC infusion or purged autologous bone marrow transplantation on day 0 followed by G-CSF SC or IV beginning 4 hours after completion of transplantation and continuing until blood counts recover. Beginning on day 66, patients receive oral isotretinoin twice daily for 14 days. Isotretinoin therapy repeats every 4 weeks for 6 courses.
After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days.
Patients not undergoing transplantation or who are ineligible for consolidation therapy receive maintenance therapy comprising cyclophosphamide IV over 30 minutes followed by topotecan IV over 30 minutes on days 0-4. Patients receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. Maintenance therapy repeats every 3 weeks for 3 courses. After completion of maintenance therapy, patients receive radiotherapy as outlined above. Patients then receive oral isotretinoin twice daily for 14 days. Isotretinoin therapy repeats every 4 weeks for 6 courses.
Quality of life is assessed at 1* and 5 years.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter or until disease progression.
NOTE: * Patients under 5 years of age at 1 year are not assessed until 5 years.
PROJECTED ACCRUAL: A total of 486 patients will be accrued for this study within 4 years.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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:
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
Less than 1 year old with the following:
Registration on protocol COG-ANBL00B1 required within 14 days of diagnosis
PATIENT CHARACTERISTICS:
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PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other
Primary purpose
Allocation
Interventional model
Masking
495 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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