cancer.duke.edu/btc  
The Preston Robert Tisch Brain Tumor Center at Duke

Clinical Trials for Pediatrics | Treatment of Patients with Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor (PNET), or Atypical Teratoid Rhabdoid Tumor (ATRT) - SJMB03

Description
During this study, researchers will look at tumor tissues to get information about genetic makeup, and look for things that are similar, different or abnormal in these tumors. Researchers hope to come up with tumor “profiles” that can predict how tumors might respond to therapy. Using this information, physicians may be able to tailor future therapies for individual tumor types, which may increase the possibility of treatment success.

Sometimes treatment to the brain can have bad side effects that affect learning, attention, school performance, cognition (thinking and learning), and memory. These side effects can cause problems with schoolwork, job performance, and everyday life. Researchers will test a computer training system that focuses on reading skills. They want to see if the system can prevent at least some loss in reading skills that sometimes occurs in brain tumor subjects.

Objectives

  • To find out how many subjects have tumors with a certain gene called ERBB2, and see if high levels of this gene affect the tumor.
  • To learn more about the way medulloblastomas and related tumors appear under the microscope and how the appearance of these tumor cells may be related to the way the cells respond to treatment.
  • To develop and test a new computer-based educational program that uses a computer to help prevent some of the loss in subjects’ reading skills and subjects’ language, reading, and learning skills.
  • To find out if the treatment effects on the nervous system (brain and spinal cord) of subjects with average-risk tumors are different from those of subjects with high-risk tumors.
  • To find new methods or improve current methods in imaging (pictures of areas inside the body) of subjects with medulloblastoma and related brain tumors

Eligibility

  • Medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), PNET variants (Ependymoblastoma, Pineoblastoma, central nervous system (CNS) neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT).
  • Age three years but not more than 21 years at the time of diagnosis.
  • No previous radiotherapy or chemotherapy.
  • Subjects must begin treatment soon after surgery.
  • Normal kidney, liver and bone marrow function.
  • Adequate performance status.

Criteria for Enrollment on the Average-Risk Arm of the Protocol

  • Localized tumor without evidence of tumor beyond the posterior fossa (or supratentorial compartment for PNET / ATRT).
  • All tumor has been removed by surgery.
  • No evidence of disease in the central nervous system.

Criteria for Enrollment on High-Risk Arm
Subjects must meet one of the two following criteria:

  • Presence of metastatic disease within the brain
  • Disease at the primary site after surgery.


Printer Friendly Page Send this Story to a Friend