Back to resultsBiomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
Primary Purpose
Brain and Central Nervous System Tumors
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
systemic chemotherapy
laboratory biomarker analysis
therapeutic surgical procedure
radiation therapy
Sponsored by
About this trial
This is an interventional basic science trial for Brain and Central Nervous System Tumors focused on measuring 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
Eligibility 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
Sites / Locations
- Childrens Hospital Los Angeles
- Lucile Packard Children's Hospital at Stanford University Medical Center
- Children's National Medical Center
- Children's Memorial Hospital - Chicago
- NCI - Pediatric Oncology Branch
- Memorial Sloan-Kettering Cancer Center
- Duke Cancer Institute
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Pittsburgh of UPMC
- St. Jude Children's Research Hospital
- Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Outcomes
Primary Outcome Measures
Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
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
Effect of treatment on lymphocytes and T-reg cells
Secondary Outcome Measures
Baseline fraction of circulating T-reg cells
Full Information
NCT ID
NCT01233479
First Posted
November 2, 2010
Last Updated
March 28, 2019
Sponsor
Pediatric Brain Tumor Consortium
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01233479
Brief Title
Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
Official Title
Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
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
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
August 24, 2017 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pediatric Brain Tumor Consortium
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
therapeutic surgical procedure
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
Title
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
Title
Effect of treatment on lymphocytes and T-reg cells
Secondary Outcome Measure Information:
Title
Baseline fraction of circulating T-reg cells
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sri Gururangan, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Lucile Packard Children's Hospital at Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
NCI - Pediatric Oncology Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
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