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Therapeutic Areas: Oncology | Pediatrics/Neonatology | Neurology
Disease Category: Neuroblastoma

Trial Information

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma COG ANBL0532

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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which regimen of myeloablation chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.

PURPOSE: This randomized phase III trial is comparing two different myeloablation therapies followed by a stem cell transplant in treating young patients with high-risk neuroblastoma.

DISEASE CHARACTERISTICS:

• Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by the presence of clumps of tumor cells in bone marrow and elevated catecholamine metabolites in urine meeting any of the following criteria:
• Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following:
  • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
  • Age > 18 months (i.e., > 547 days) regardless of biologic features
  • Age 12-18 months (i.e., 365-547 days) with none of the following three favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and DNA index > 1)
• Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:
  • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
  • Age > 18 months (i.e., > 547 days) with unfavorable pathology, regardless of MYCN status
  • Patients with newly diagnosed INSS stage 2a or 2b with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
  • Patients with newly diagnosed INSS stage 4s with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features
  • Patients = 365 days initially diagnosed with INSS stage 1, 2, or 4S and who progressed to a stage 4 without interval chemotherapy
• Must have been enrolled on COG-ANBL00B1

PATIENT CHARACTERISTICS:

• Creatinine clearance or radioisotope glomerular filtration rate = 70mL/min OR serum creatinine based on age/gender as follows:
  • 1 month to < 6 months: 0.4 mg/dL
  • 6 months to < 1 year: 0.5 mg/dL
  • 1 to < 2 years: 0.6 mg/dL
  • 2 to < 6 years: 0.8 mg/dL
  • 6 to < 10 years: 1 mg/dL
  • 10 to < 13 years: 1.2 mg/dL
  • 10 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
  • ≥16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
• Total bilirubin = 1.5 times upper limit of normal (ULN) for age
• AST or ALT < 10 times ULN for age
• Not pregnant or nursing
• Negative pregnancy test
• Shortening fraction = 27% by ECHO OR LVEF ≥ 50% by radionuclide angiogram
• No known contraindication (e.g., size, weight or physical condition) to peripheral blood stem cell collection

PRIOR CONCURRENT THERAPY:

• No prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease
• No more than one course of chemotherapy per low- or intermediate-risk neuroblastoma therapy prior to determination of MYCN amplification and histology

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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