Trial Search Results

Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: cyclophosphamide
  • Drug: topotecan hydrochloride
  • Drug: cisplatin
  • Drug: etoposide
  • Drug: vincristine sulfate
  • Drug: doxorubicin hydrochloride
  • Radiation: external beam radiation therapy
  • Drug: busulfan
  • Drug: melphalan
  • Procedure: autologous hematopoietic stem cell transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
  • Biological: filgrastim
  • Drug: mesna

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Patients must have a diagnosis of neuroblastoma (International Classification of
   Diseases for Oncology [ICD-O] morphology 9500/3) or ganglioneuroblastoma (nodular or
   intermixed) verified by histology or demonstration of clumps of tumor cells in bone
   marrow with elevated urinary catecholamine metabolites; patients with the following
   disease stages at diagnosis are eligible, if they meet the other specified criteria

   - Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging
   System (INSS) stage 4 are eligible with the following:

      - V-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN)
      amplification (> 4-fold increase in MYCN signals as compared to reference
      signals), regardless of age or additional biologic features or

      - Age > 18 months (> 547 days) regardless of biologic features or

      - Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic
      features (MYCN amplification, unfavorable pathology and/or deoxyribonucleic acid
      [DNA] index = 1) or any biologic feature that is
      indeterminate/unsatisfactory/unknown

   - Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the
   following:

      - MYCN amplification (> 4-fold increase in MYCN signals as compared to reference
      signals), regardless of age or additional biologic features or

      - Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN
      status

   - Patients with newly diagnosed neuroblastoma with INSS stage 2A/2B with MYCN
   amplification (> 4-fold increase in MYCN signals as compared to reference signals),
   regardless of age or additional biologic features

   - Patients with newly diagnosed neuroblastoma with INSS stage 4S with MYCN amplification
   (> 4-fold increase in MYCN expression signals as compared to reference signals),
   regardless of additional biologic features

   - Patients >= 365 days initially diagnosed with neuroblastoma INSS stage 1, 2, 4S who
   progressed to a stage 4 without interval chemotherapy; these patients must have been
   enrolled on ANBL00B1; study enrollment on ANBL12P1 must occur within 4 weeks of
   progression to stage 4 for INSS stage 1, 2, 4S

   - Patients must not have had prior systemic therapy except for localized emergency
   radiation to sites of life-threatening or function-threatening disease and/or no more
   than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as
   per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification
   status and histology

   - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
   mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

      - Age 1 month to < 6 months: 0.4 mg/dL

      - Age 6 months to < 1 year: 0.5 mg/dL

      - Age 1 to < 2 years: 0.6 mg/dL

      - Age 2 to < 6 years: 0.8 mg/dL

      - Age 6 to < 10 years: 1 mg/dL

      - Age 10 to < 13 years: 1.2 mg/dL

      - Age 13 to < 16 years: 1.5 mg/dL (males), 1.4 mg/dL (females)

      - Age >= 16 years: 1.7 mg/dL (males), 1.4 mg/dL (females)

   - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and

   - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
   serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x
   ULN for age

   - Shortening fraction of >= 27% by echocardiogram, or

   - Ejection fraction of >= 50% by radionuclide evaluation

   - No known contraindication to peripheral blood stem cell (PBSC) collection; examples of
   contraindications might be a weight or size less than that determined to be feasible
   at the collecting institution, or a physical condition that would limit the ability of
   the child to undergo apheresis catheter placement (if necessary) and/or the apheresis
   procedure

   - All patients and/or their parents or legal guardians must sign a written informed
   consent

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic
   features (ie, nonamplified MYCN, favorable pathology, and DNA index > 1) are not
   eligible

   - Female patients who are pregnant are ineligible

   - Lactating females are not eligible unless they have agreed not to breastfeed their
   infants

   - Female patients of childbearing potential are not eligible unless a negative pregnancy
   test result has been obtained

   - Sexually active patients of reproductive potential are not eligible unless they have
   agreed to use an effective contraceptive method for the duration of their study
   participation

Ages Eligible for Study

N/A - 30 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting