Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
This study has been withdrawn prior to enrollment.
(This non-therapeutic study was registered in error. The PRS team doesn't delete studies once registered, so they recommended changing the status to Withdrawn)
Sponsor:
Pediatric Brain Tumor Consortium
Collaborator:
Information provided by:
Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:
NCT01233479
First received: November 2, 2010
Last updated: October 19, 2012
Last verified: October 2012
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Purpose
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 | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors |
Drug: systemic chemotherapy Other: laboratory biomarker analysis Procedure: therapeutic surgical procedure Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pediatric Brain Tumor Consortium:
Primary Outcome Measures:
- Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Effect of treatment on lymphocytes and T-reg cells [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Baseline fraction of circulating T-reg cells [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 4 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233479
Locations
| United States, California | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | |
| Palo Alto, California, United States, 94304 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Maryland | |
| NCI - Pediatric Oncology Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Duke Cancer Institute | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |
| Houston, Texas, United States, 77030-2399 | |
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
Investigators
| Principal Investigator: | Sri Gururangan, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | James M. Boyett, Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT01233479 History of Changes |
| Other Study ID Numbers: | CDR0000673892, PBTC-N11 |
| Study First Received: | November 2, 2010 |
| Last Updated: | October 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pediatric Brain Tumor Consortium:
|
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 |
Additional relevant MeSH terms:
|
Medulloblastoma Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013