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

This study has been withdrawn prior to enrollment.
(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 The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn)
Sponsor:
Collaborator:
Information provided by:
Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:
NCT01233479
First received: November 2, 2010
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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 Intervention
Brain and Central Nervous System Tumors
Drug: systemic chemotherapy
Other: laboratory biomarker analysis
Procedure: therapeutic surgical procedure
Radiation: radiation therapy

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Pediatric Brain Tumor Consortium:

Primary Outcome Measures:
  • Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Effect of treatment on lymphocytes and T-reg cells [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline fraction of circulating T-reg cells [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2010
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233479

Locations
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
Investigators
Principal Investigator: Sri Gururangan, MD Duke Cancer Institute
  More Information

No publications provided

Responsible Party: James M. Boyett, Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier: NCT01233479     History of Changes
Other Study ID Numbers: CDR0000673892, PBTC-N11
Study First Received: November 2, 2010
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

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:
Central Nervous System Neoplasms
Medulloblastoma
Nervous System Neoplasms
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive

ClinicalTrials.gov processed this record on November 27, 2014