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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01233479
• Other study ID #: CDR0000673892
• Secondary ID: PBTC-N11
• Status: Withdrawn
• Phase: N/A
• Start date: May 2010
• Est. completion date: August 24, 2017

Study information

• Verified date: March 2019
• Source: Pediatric Brain Tumor Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 24, 2017
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Medulloblastoma
• Nervous System Neoplasms

Intervention

Drug:
• systemic chemotherapy

Other:
• laboratory biomarker analysis

Procedure:
• therapeutic surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	NCI - Pediatric Oncology Branch	Bethesda	Maryland
United States	Children's Memorial Hospital - Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke Cancer Institute	Durham	North Carolina
United States	Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital	Houston	Texas
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Lucile Packard Children's Hospital at Stanford University Medical Center	Palo Alto	California
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Pediatric Brain Tumor Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation
Primary	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
Primary	Effect of treatment on lymphocytes and T-reg cells
Secondary	Baseline fraction of circulating T-reg cells