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

Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01233479
Enrollment
0
Registered
2010-11-03
Start date
2010-05-31
Completion date
2017-08-24
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGsystemic chemotherapy
OTHERlaboratory biomarker analysis
RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Pediatric Brain Tumor Consortium
Lead SponsorNETWORK

Study design

Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Baseline fraction of circulating T-reg cells

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026