Clinical trial NCT00897858: Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
Official title: Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children With Newly Diagnosed Central Nervous System Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain and Central Nervous System Tumors
Keywords: childhood central nervous system germ cell tumor
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
childhood atypical teratoid/rhabdoid tumor
untreated childhood visual pathway glioma
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
childhood craniopharyngioma
untreated childhood medulloblastoma
untreated childhood cerebellar astrocytoma
untreated childhood supratentorial primitive neuroectodermal tumor
untreated childhood brain stem glioma
untreated childhood visual pathway and hypothalamic glioma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
childhood central nervous system choriocarcinoma
childhood central nervous system embryonal tumor
childhood central nervous system germinoma
childhood central nervous system mixed germ cell tumor
childhood central nervous system teratoma
childhood central nervous system yolk sac tumor
Lead sponsor: Pediatric Brain Tumor Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 0
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of newly diagnosed pediatric patients with a CNS tumor and no prior irradiation or chemotherapy. Cerebrospinal fluid (CSF) is withdrawn as part of initial diagnosis/staging, the administration of intrathecal therapy, or CSF diversion.

Brief summary: RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.

Detailed description: OBJECTIVES:

Primary

* Investigate the feasibility of centrally collecting and processing high-quality cerebrospinal fluid (CSF) samples from pediatric patients with newly diagnosed central nervous system tumors for proteomic studies.
* Identify protein markers that might indicate the presence of a brain tumor using CSF samples collected from these patients.

OUTLINE: This is a multicenter study.

Patients undergo cerebrospinal fluid (CSF) collection from any or all of the following 5 sites: lumbar, cervical, ommaya, intra-operative (ventricular, cisternal), and/or external ventricular drain. CSF is obtained within 8 weeks of diagnosis but prior to (or concurrent with) the initiation of any post-operative therapy (excluding corticosteroids).

CSF samples are examined for proteomic biomarkers by 2D gel electrophoresis, low-mass fingerprinting, and stable isotope labeling.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed CNS tumors of any of the following histologies:

  * Diffuse pontine gliomas\*
  * Focal/infiltrative tumors, including any of the following:

    * High- and low-grade gliomas
    * Gangliogliomas
    * Ependymomas
    * Oligodendrogliomas
    * Craniopharyngioma
    * Dysembryoplastic neuroepithelial tumors
    * Other low-grade neoplasms
  * Optic pathway gliomas\*
  * Seeding tumors, including any of the following:

    * Germ cell tumors (germinomas and nongerminomas)
    * Embryonal tumors, including any of the following:

      * Medulloblastoma
      * Pineoblastoma
      * Supratentorial primitive neuroectodermal tumors
      * Atypical teratoid/rhabdoid tumor
      * Other embryonal tumors NOTE: \*Histological requirement waived
* Newly diagnosed disease
* Cerebrospinal fluid (CSF) obtained as part of CSF diversion, initial diagnosis/staging, or administration of intrathecal chemotherapy (at the initiation of postoperative therapy)

PATIENT CHARACTERISTICS:

* Less than 22 years of age

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy or chemotherapy
* Prior corticosteroids allowed

Primary outcomes:
measure: Number of IRB approvals of the study
timeFrame: Within 120 days of study release
measure: Number of patients with proteomic data received at the Operations and Biostatistics Center
timeFrame: 12, 18, 24, and 30 months after 4th IRB approval
measure: Number of differentially expressed biomarker proteins
timeFrame: Pre-treatment
Secondary outcomes:
Other outcomes:
Locations:
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: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center - Seattle
state: Washington
Study officials:
affiliation: Children's National Research Institute
name: Brian R. Rood, MD
role: STUDY_CHAIR
References: