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Status:

UNKNOWN

Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors

Lead Sponsor:

Children's Hospital Los Angeles

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

Up to 10 years

Phase:

PHASE3

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. A bone marrow or peripheral stem cell tra...

Detailed Description

OBJECTIVES: Primary * Determine the 2-year event-free survival (EFS) and overall survival (OS) of pediatric patients with previously untreated nondisseminated medulloblastoma (\< 4 years of age), di...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed malignant brain tumor, including any of the following:
  • Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET)\*
  • All stages allowed
  • Must be \< 4 years of age at diagnosis unless there is evidence of postoperative residual tumor (\> 1.5 cm² tumor area) or evidence of neuraxis or extraneural dissemination (high-stage)
  • Medulloblastoma, cerebral neuroblastoma, and ependymoblastoma allowed
  • Low-stage (standard-risk) medulloblastoma not allowed in patients \> 4 years of age
  • Ependymoma\*
  • All stages and locations allowed
  • Cellular and anaplastic subtypes allowed (no myxopapillary ependymomas of the spinal cord)
  • Must be \< 36 months of age at diagnosis for posterior fossa tumor OR \< 72 months of age for supratentorial tumor
  • Evidence of neuraxis dissemination irrespective of primary site
  • No cellular (low-grade) supratentorial ependymomas at any age with complete resection of parenchymally based (i.e., not periventricular) supratentorial tumors
  • Brain stem tumor\*
  • All stages allowed irrespective of extent of resection
  • No unbiopsied diffuse intrinsic pontine tumor
  • Tumor pathologically confirmed to be either malignant glioma or PNET allowed
  • High-grade glioma\*\*
  • Primary atypical teratoid/rhabdoid tumor of the CNS\*
  • Choroid plexus carcinoma or atypical choroid plexus papilloma\*
  • All stages and locations allowed
  • Anaplastic astrocytoma\*\*
  • Glioblastoma multiforme\*\*
  • Anaplastic oligodendroglioma\*\*
  • Anaplastic ganglioglioma\*\*
  • Other anaplastic mixed gliomas\*\*
  • Small-cell glioblastoma\*\*
  • Giant-cell glioblastoma\*\*
  • Gliosarcoma\*\*
  • The following diagnoses or subtypes are not allowed:
  • Choroid plexus papilloma
  • Pineocytoma
  • Low-grade mixed glioma
  • Primary CNS germ cell tumor
  • Primary CNS lymphoma
  • Solid leukemic lesions (i.e., chloromas, granulocytic sarcomas)
  • Pleomorphic xanthoastrocytoma, low grade
  • Desmoplastic ganglioglioma
  • Low-grade astrocytoma
  • Previously untreated disease
  • Has undergone definitive surgery within the past 42 days NOTE: \*Patients receive treatment according to regimen D2
  • NOTE: \*\*Patients receive treatment according to regimen C
  • PATIENT CHARACTERISTICS:
  • Bilirubin \< 1.5 mg/dL
  • ALT and AST \< 2.5 times upper limit of normal
  • Creatinine clearance and/or glomerular filtration rate ≥ 60 mL/min
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior radiotherapy or chemotherapy
  • Prior corticosteroids allowed
  • No concurrent corticosteroids for antiemesis only
  • No concurrent brachytherapy or electron radiotherapy
  • No concurrent dairy products or grapefruit juice with temozolomide administration

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT00392886

    Start Date

    March 1 2004

    Last Update

    December 18 2013

    Active Locations (37)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 10 (37 locations)

    1

    Phoenix Children's Hospital Outpatient Center

    Phoenix, Arizona, United States, 85016

    2

    Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, United States, 92354

    3

    Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, United States, 90806

    4

    Childrens Hospital Los Angeles

    Los Angeles, California, United States, 90027