- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01233479
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
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90027-0700
- Childrens Hospital Los Angeles
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Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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District of Columbia
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Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical Center
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Illinois
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Chicago, Illinois, Forente stater, 60614
- Children's Memorial Hospital - Chicago
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Maryland
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Bethesda, Maryland, Forente stater, 20892
- NCI - Pediatric Oncology Branch
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New York
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New York, New York, Forente stater, 10065
- Memorial Sloan-Kettering Cancer Center
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke Cancer Institute
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Ohio
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Cincinnati, Ohio, Forente stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Children's Hospital of Pittsburgh of UPMC
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Tennessee
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Memphis, Tennessee, Forente stater, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, Forente stater, 77030-2399
- Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
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
|
Sekundære resultatmål
Resultatmål |
---|
Baseline fraction of circulating T-reg cells
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sri Gururangan, MD, Duke Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- ubehandlet hjernestammegliom fra barndommen
- ubehandlet medulloblastom i barndommen
- ubehandlet cerebellar astrocytom i barndommen
- ubehandlet cerebralt astrocytom i barndommen
- barndom medulloepithelioma
- infratentorielt ependymom i barndommen
- nydiagnostisert barneependymom
- barndom atypisk teratoid/rhabdoid svulst
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer, kjertel og epitel
- Glioma
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Neuroektodermale svulster, primitive
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Medulloblastom
Andre studie-ID-numre
- CDR0000673892
- PBTC-N11
Legemiddel- og utstyrsinformasjon, studiedokumenter
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