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Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor
Overall Recruitment Status: Active, enrollment completed
 
Official Title
Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
 
Region Sponsors
California - Northern
Children's Oncology Group
 
Acronym KP IRB No.
CN-07VKile-10-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Patients with brain and Central Nervous System Tumors
 
Purpose
This randomized phase III trial is studying different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumor. 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 more than one drug (combination chemotherapy) may kill more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
 
Detailed Description
This is a randomized, open-label, factorial-designed, multicenter study. Patients are stratified according to location of disease and dissemination status (M0 medulloblastoma with > 1.5 cm² residual tumor vs M+ medulloblastoma vs M0 supratentorial primitive neuroectodermal tumor [SPNET] with < 1.5 cm² residual tumor vs M0 SPNET with > 1.5 cm² residual tumor vs M+ SPNET vs M0 diffusely anaplastic medulloblastoma ). Patients are randomized to 1 of 4 treatment arms.
 
Gender Age Limit
Male & Female 3 - 21 years
 
Inclusion Criteria
  • Histologically confirmed diagnosis of medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET)
  • Must have undergone stereotactic biopsy or attempted neurosurgical resection of the tumor within the past 31 days
  • Karnofsky performance status (PS) 30-100% (for patients > 16 years of age) OR Lansky PS 30-100% (for patients < or = 16 years of age)
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2.5 times ULN (5 times ULN for patients on antiseizure medications)
 
Exclusion Criteria
  • Patients with M4 disease
  • Patients who are pregnant or nursing
  • Absolute neutrophil count < 1,000/mm³
  • Platelet count < 100,000/mm³ (transfusions not allowed)
  • Hemoglobin < 8 g/dL (transfusions allowed)

 
Keywords and/or Specific Medical Conditions
  • brain
  • isotretinoin
  • carboplatin
  • medulloblastoma
  • central nervous system
  • neoplasms
  • children's oncology group
  • radiation therapy
  • cisplatin
  • supratentorial primitive neuroectodermal tumor
  • CNS
  • vincristine sulfate
  • cyclophosphamide
  • COG
  • filgrastim
  • Oncology (Pediatrics)
  • glioma
  • radiology
 
KP Clinical Facility
  • Oakland Medical Center
  • Roseville Medical Center
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Oncology (Pediatrics)
  • Radiology


Principal Investigator:
Laura Campbell, MD
Contact Information:
- Susan D Ledesma
-916-787-6576
-susan.d.ledesma@kp.org
-Roseville Medical Center
- Susan X Leu
-916-474-2306
-susan.x.leu@kp.org
-Roseville Medical Center


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