Trials / Withdrawn
WithdrawnNCT01233479
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- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Pediatric Brain Tumor Consortium · Network
- Sex
- All
- Age
- 4 Years – 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | systemic chemotherapy | |
| OTHER | laboratory biomarker analysis | |
| PROCEDURE | therapeutic surgical procedure | |
| RADIATION | radiation therapy |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2011-07-01
- Completion
- 2017-08-24
- First posted
- 2010-11-03
- Last updated
- 2019-04-01
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01233479. Inclusion in this directory is not an endorsement.