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Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00897858
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Pediatric Brain Tumor Consortium
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Brian R. Rood, MD
Principal Investigator Affiliation Children's National Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Arms & Interventions

Arms

: Pediatric CNS tumor patients

Newly diagnosed pediatric patients with CNS tumor and no prior irradiation or chemotherapy

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010-2970

Children's Memorial Hospital - Chicago, Chicago, Illinois

Status

Address

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213

Houston, Texas

Status

Address

Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

Houston, Texas, 77030-2399

Seattle, Washington

Status

Address

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105

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