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)
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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