Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Pediatric Brain Tumor Consortium

Brian Richard Rood

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00897858
Information obtained from ClinicalTrials.gov on March 05, 2012

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