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

Sponsor

Pediatric Brain Tumor Consortium (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01233479

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

87.8

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: systemic chemotherapy Other: laboratory biomarker analysis Procedure: therapeutic surgical procedure Radiation: radiation therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Masking:

None (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

Study Start Date :

May 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Aug 24, 2017

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Childrens Hospital Los Angeles	Los Angeles	California	United States	90027-0700
2	Lucile Packard Children's Hospital at Stanford University Medical Center	Palo Alto	California	United States	94304
3	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
4	Children's Memorial Hospital - Chicago	Chicago	Illinois	United States	60614
5	NCI - Pediatric Oncology Branch	Bethesda	Maryland	United States	20892
6	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
7	Duke Cancer Institute	Durham	North Carolina	United States	27710
8	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
9	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15213
10	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105
11	Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital	Houston	Texas	United States	77030-2399