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Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy

4 Years
21 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy



- Evaluate the fraction of peripherally circulating T-regulatory cells (T_regs) in
pediatric patients with newly diagnosed medulloblastoma and compare it to the levels
found in a control group of patients undergoing craniectomy for Chiari malformation.

- Evaluate the longitudinal effects of standard radiotherapy and chemotherapy regimens on
the overall population of lymphocytes as well as the fraction of T_reg cells in
patients with medulloblastoma.


- Determine the baseline fraction of T_reg cells in those with non-medulloblastoma
posterior fossa tumors compared to levels found in patients undergoing decompression
for Chiari malformation.

OUTLINE: This is a multicenter study.

Patients with Chiari malformation and patients with posterior fossa tumor undergo standard
surgery. Patients with posterior fossa tumor also receive standard radiotherapy and

Blood samples are collected at baseline and periodically to measure the level of circulating
T-regulatory cells.

Inclusion Criteria


- Meets 1 of the following criteria:

- Histologically confirmed posterior fossa tumor

- Newly diagnosed disease

- Medulloblastoma OR non-medulloblastoma (pilocytic astrocytoma, ependymoma,
atypical rhabdoid tumor, or others)

- Scheduled to undergo craniotomy and tumor resection

- Chiari malformation

- Requires craniectomy for decompression

- No secondary decompression


- No unexplained febrile illness

- No active infection

- No autoimmune disorders such as inflammatory bowel disease, juvenile rheumatoid
arthritis, or systemic lupus erythematosus

- No other immunosuppressive disorders (e.g., HIV infection)


- See Disease Characteristics

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation

Safety Issue:


Principal Investigator

Sri Gururangan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood medulloblastoma
  • untreated childhood cerebellar astrocytoma
  • untreated childhood cerebral astrocytoma
  • untreated childhood brain stem glioma
  • childhood medulloepithelioma
  • childhood infratentorial ependymoma
  • newly diagnosed childhood ependymoma
  • childhood atypical teratoid/rhabdoid tumor
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Childrens Hospital Los Angeles Los Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto, California  95798
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Duke Cancer Institute Durham, North Carolina  27710
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital Houston, Texas  77030-2399
NCI - Pediatric Oncology Branch Bethesda, Maryland