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Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01233479
Recruitment Status : Withdrawn (This non-therapeutic study was registered in error. The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn)
First Posted : November 3, 2010
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Pediatric Brain Tumor Consortium

Study Description
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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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: systemic chemotherapy Other: laboratory biomarker analysis Procedure: therapeutic surgical procedure Radiation: radiation therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy
Study Start Date : May 2010
Estimated Primary Completion Date : July 2011
Actual Study Completion Date : August 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
  2. 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
  3. Effect of treatment on lymphocytes and T-reg cells

Secondary Outcome Measures :
  1. Baseline fraction of circulating T-reg cells

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233479


Locations
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United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 94304
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
United States, Maryland
NCI - Pediatric Oncology Branch
Bethesda, Maryland, United States, 20892
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, United States, 77030-2399
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sri Gururangan, MD Duke Cancer Institute
More Information
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Responsible Party: James M. Boyett, Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier: NCT01233479    
Other Study ID Numbers: CDR0000673892
PBTC-N11
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Keywords provided by Pediatric Brain Tumor Consortium:
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
Additional relevant MeSH terms:
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Nervous System Neoplasms
Medulloblastoma
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Glioma
 Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue