Clinical trial NCT01233479: Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
Official title: Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain and Central Nervous System Tumors
Keywords: 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
Lead sponsor: Pediatric Brain Tumor Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: BASIC_SCIENCE

Brief summary: RATIONALE: Studying samples of blood in the laboratory from patients receiving radiation therapy and chemotherapy may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in blood samples from young patients with newly diagnosed brain tumors undergoing standard radiation therapy and chemotherapy.

Detailed description: OBJECTIVES:

Primary

* 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.

Secondary

* 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 chemotherapy.

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

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

* 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)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
measure: Longitudinal side effects of standard radiotherapy and chemotherapy regimens on the overall population of lymphocytes as well as the fraction of circulating T-reg cells
measure: Effect of treatment on lymphocytes and T-reg cells
Secondary outcomes:
measure: Baseline fraction of circulating T-reg cells
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford University Medical Center
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Children's Memorial Hospital - Chicago
state: Illinois
city: Bethesda
country: United States
facility: NCI - Pediatric Oncology Branch
state: Maryland
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
state: Texas
Study officials:
affiliation: Duke Cancer Institute
name: Sri Gururangan, MD
role: PRINCIPAL_INVESTIGATOR
References: