Status:
COMPLETED
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
3-21 years
Phase:
PHASE3
Brief Summary
Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-ener...
Detailed Description
SECONDARY OBJECTIVES: * To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Medulloblastoma
- Supratentorial primitive neuroectodermal tumor (PNET)
- PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma)
- Atypical teratoid rhabdoid tumor (ATRT)
- Definitive surgery for CNS tumor within the past 31 days
- Meets one of the following risk criteria:
- Average-risk disease
- Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI
- T4 disease eligible if all of the following are true:
- Gross total resection determined by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI
- Residual tumor or imaging abnormality whose size is \< 1.5 cm\^2
- No evidence of CNS or extraneural metastasis by MRI of the spine (with and without contrast agent) or CT-based myelogram AND by cytologic examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after surgery
- Brain stem invasion allowed in the absence of residual tumor (tumor \< 1.5 cm\^2 by imaging)
- High-risk disease meeting one of the following criteria:
- Metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination by imaging and/or cytologic examination of CSF)
- Presence of residual disease \> 1.5 cm\^2 at the primary site after surgery
- PATIENT CHARACTERISTICS:
- Age
- 3 to 21 at diagnosis
- Performance status
- Lansky 30-100% (\< 10 years old)
- Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome)
- Life expectancy
- Not specified
- Hematopoietic
- Hemoglobin \> 8 g/dL
- WBC \> 2,000/mm\^3
- Absolute neutrophil count \> 500/mm\^3
- Platelet count \> 50,000/mm\^3
- Hepatic
- ALT \< 5 times normal
- Bilirubin \< 3.0 mg/dL
- Renal
- Creatinine \< 2.0 mg/dL OR
- Creatinine clearance \> 70 mL/min
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy
- Endocrine therapy
- Prior corticosteroid therapy allowed
- Radiotherapy
- No prior radiotherapy
- Surgery
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00085202
Start Date
August 1 2003
End Date
December 31 2023
Last Update
February 8 2024
Active Locations (9)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
4
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, United States, 77030-2399