Skip to main content
Clinical Trials/NCT01233479
NCT01233479
Withdrawn
Not Applicable

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

Pediatric Brain Tumor Consortium11 sites in 1 countryMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain and Central Nervous System Tumors
Sponsor
Pediatric Brain Tumor Consortium
Locations
11
Primary Endpoint
Effect of treatment on lymphocytes and T-reg cells
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
August 24, 2017
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Pediatric Brain Tumor Consortium

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Effect of treatment on lymphocytes and T-reg cells

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

Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation

Secondary Outcomes

  • Baseline fraction of circulating T-reg cells

Study Sites (11)

Loading locations...

Similar Trials