Brain and Central Nervous System TumorsNCT01233479
Biomarkers in Blood Samples From Young Patients With Newly Diagnosed Brain Tumors Undergoing Standard Radiation Therapy and Chemotherapy
A study testing systemic chemotherapy, laboratory biomarker analysis and therapeutic surgical procedure in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- systemic chemotherapy, laboratory biomarker analysis and therapeutic surgical procedure
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2010to 24 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
NCI - Pediatric Oncology Branch
Bethesda, Maryland, 20892
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Duke Cancer Institute
Durham, North Carolina, 27710
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, 77030-2399
Childrens Hospital Los Angeles
Los Angeles, California, 90027-0700
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, 94304
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy
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.
Read the 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
- Brain and Central Nervous System Tumors
- Being tested
- systemic chemotherapy, laboratory biomarker analysis, therapeutic surgical procedure, radiation therapy
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Rhabdoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic chemotherapyDrug
laboratory biomarker analysisOther
therapeutic surgical procedureProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Baseline fraction of circulating T-reg cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2011 (estimated)
- Study completion24 Aug 2017
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Brain Tumor Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Sri Gururangan, MD, Principal investigator, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233479
- Sponsor's protocol ID
- CDR0000673892
- Other IDs
- PBTC-N11
- Status last verified
- Mar 2019
- First submitted
- 2 Nov 2010
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Profile of Patients With Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy
- ClinicalTrials.gov ID
- NCT01233479
- Acronym / sponsor ID
- CDR0000673892
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pediatric Brain Tumor ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systemic chemotherapy | Drug | – |
| laboratory biomarker analysis | Other | – |
| therapeutic surgical procedure | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
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
1 secondary outcome
Baseline fraction of circulating T-reg cells
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sri Gururangan, MD principal investigator
Duke Cancer Institute
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systemic chemotherapy, laboratory biomarker analysis and therapeutic surgical procedure in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripherally circulating T-regulatory (T-reg) cells in patients with medulloblastoma or Chiari malformation. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.