- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003203
Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors
An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors
RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Determine the feasible dose and duration of carboplatin combined with craniospinal and local radiotherapy and adjuvant chemotherapy in children with newly diagnosed, high-risk CNS embryonal tumors (Phase I completed as of 11-25-03).
- Determine the feasibility of administering cyclophosphamide and vincristine with or without cisplatin after concurrent carboplatin, vincristine, and radiotherapy in these patients.
- Determine the overall and individual toxicity rates of this regimen in these patients.
- Determine the complete response rate in patients treated with this regimen.
- Obtain preliminary estimates of event-free survival of patients treated with this regimen.
- Determine the prognostic significance of enhancing tumor after completion of radiotherapy on event-free survival of these patients.
OUTLINE: This is a pilot, dose-escalation study of carboplatin. (Phase I completed as of 11-25-03.)
Within 31 days of definitive surgery, all patients receive vincristine IV weekly for 6 weeks and carboplatin IV over 15-20 minutes (after completion of vincristine infusion) 5 days a week for 6 weeks. Patients undergo radiotherapy (1-4 hours after carboplatin infusion) 5 days a week for 6 weeks.
Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 12 patients experience dose-limiting toxicity. (Phase I completed as of 11-25-03.)
At 6 weeks after completion of radiotherapy, patients are assigned to arm II for adjuvant/maintenance chemotherapy. (Arm I closed to accrual as of 11-25-03.)
- Arm I (closed to accrual as of 11-25-03): Patients receive cyclophosphamide IV over 1 hour on days 0 and 1, vincristine IV on days 0 and 7, and filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 2 and continuing for at least 10 days until blood counts recover.
- Arm II: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2, vincristine IV on days 0 and 7, cisplatin IV over 6 hours on day 0, and G-CSF IV or SC beginning on day 3 and continuing for at least 10 days until blood counts recover.
In both arms, adjuvant/maintenance chemotherapy repeats every 4 weeks for 6 courses.
Patients are followed every 3 months for 8 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Western Australia
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Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3J 3G9
- IWK Grace Health Centre
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California
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Long Beach, California, Forenede Stater, 90806
- Long Beach Memorial Medical Center
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, Forenede Stater, 92668
- Children's Hospital of Orange County
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San Francisco, California, Forenede Stater, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Children's Hospital of Denver
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Cancer Research Center
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202-5265
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Kalamazoo, Michigan, Forenede Stater, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198-3330
- University of Nebraska Medical Center
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New Jersey
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Paterson, New Jersey, Forenede Stater, 07503
- St. Joseph's Hospital and Medical Center
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New York
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- CCOP - Merit Care Hospital
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, Forenede Stater, 43205-2696
- Children's Hospital of Columbus
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Oregon
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Portland, Oregon, Forenede Stater, 97201-3098
- Doernbecher Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Cancer Center
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt Cancer Center
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas - MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Forenede Stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically proven high-risk CNS embryonal tumors, including:
- Primitive neuroectodermal tumors
- Atypical teratoid/rhabdoid tumor
- Medulloblastoma
- Desmoplastic medulloblastoma
- Ependymoblastoma
- Medullomyoblastoma
- Spongioblastoma
- Spongioblastoma polare
- Primitive polar spongioblastoma
- Neuroepitheliomatous neoplasms
- Medulloepithelioma
- Neuroblastoma
- Pineoblastoma
- No bone marrow involvement or bone metastases
- No M4 disease
- M3 disease must have evidence of tumor on spinal MRI
PATIENT CHARACTERISTICS:
Age:
- 3 to 21 at diagnosis
Performance status:
- Not specified
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count at least 100,000/mm^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (packed red blood cell transfusions allowed)
Hepatic:
- Bilirubin less than 1.5 mg/dL
- SGOT/SGPT less than 2.5 times normal
Renal:
- Creatinine less than 1.5 times upper limit of normal OR
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Prior definitive surgery allowed
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Newly diagnosed cerebral PNET with histologic verification
Begin therapy within 31 days of surgery.
Radiation therapy will be given in standard fractions along with filgrastim.
The craniospinal axis will be treated first.
Patients will receive carboplatin at 35 mg/m2/day IV over 15-20 minutes Monday through Friday, 1-4 hours prior to radiation for 6 weeks (total of 30 doses).
Vincristine sulfate 1.5 mg/m2 IV will be given weekly x 6.
Following radiation, patients will receive Maintenance chemotherapy.
Patients enrolled prior to Amendment #5 will receive six cycles of cyclophosphamide and vincristine (Regimen A).
Patients enrolled after Amendment #5 will receive six cycles of cyclophosphamide, vincristine sulfate and cisplatin (Regimen B).
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Givet IV
Andre navne:
Givet IV
Andre navne:
Givet IV
Andre navne:
Givet IV
Andre navne:
Givet IV
Andre navne:
1.8 Gy/fx x 20fx=36Gy Craniospinal XRT*
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Event Free Survival
Tidsramme: Length of study
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Minimum time to disease progression or recurrence, time to death for any reason, or time to occurrence of a second malignant neoplasm (SMN).
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Length of study
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Survival
Tidsramme: Length of study
|
Time to death from any cause
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Length of study
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Regina Jakacki, MD, University of Pittsburgh
Publikationer og nyttige links
Generelle publikationer
- Jakacki RI, Burger PC, Zhou T, Holmes EJ, Kocak M, Onar A, Goldwein J, Mehta M, Packer RJ, Tarbell N, Fitz C, Vezina G, Hilden J, Pollack IF. Outcome of children with metastatic medulloblastoma treated with carboplatin during craniospinal radiotherapy: a Children's Oncology Group Phase I/II study. J Clin Oncol. 2012 Jul 20;30(21):2648-53. doi: 10.1200/JCO.2011.40.2792. Epub 2012 Jun 4.
- Jakacki R, Burger P, Zhou T, et al.: Outcome for metastatic (M+) medulloblastoma (MB) treated with carboplatin during craniospinal radiotherapy (CSRT) followed by cyclophosphamide (CPM) and vincristine (VCR): preliminary results of COG 99701. [Abstract] J Clin Oncol 25 (Suppl 18): A-2017, 2007.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Neoplasmer efter histologisk type
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroektodermale tumorer, primitive
- Neuroektodermale tumorer, primitive, perifere
- Neoplasmer
- Neoplasmer i nervesystemet
- Neoplasmer i centralnervesystemet
- Neuroblastom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Cyclofosfamid
- Carboplatin
- Cisplatin
- Vincristine
Andre undersøgelses-id-numre
- A9971
- COG-A9971 (Anden identifikator: Children's Oncology Group)
- CCG-99701 (Anden identifikator: Children's Cancer Group)
- CDR0000066055 (Anden identifikator: Clinical Trials.gov)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Neuroblastom
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Baylor College of MedicineNew Approaches to Neuroblastoma Therapy ConsortiumAfsluttetNEUROBLASTOMAForenede Stater
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Instituto de Investigacion Sanitaria La FeAfsluttetLAV OG MELLEMMIDDEL PÆDIATRISK NEUROBLASTOMA OG NEONATAL SUPRARENAL MASSERSpanien, Italien, Belgien, Danmark, Sverige, Norge, Israel, Schweiz, Australien, Østrig
Kliniske forsøg med adjuverende terapi
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Rekruttering
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Douglas MenninWeill Medical College of Cornell University; Kent State UniversityAfsluttetGeneraliseret angstlidelse | Depression, angst | Angstlidelser og symptomer | Følelsesmæssig dysfunktionForenede Stater
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National University Hospital, SingaporeNational University, Singapore; Agency for Science, Technology and ResearchAfsluttet
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University of PennsylvaniaAfsluttetTilbagevendende Clostridium Difficile-infektionForenede Stater
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Utah State UniversityUkendt
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Medical College of WisconsinAktiv, ikke rekrutterendeProstatakræftForenede Stater
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EP SciencesUkendtHjerteelektrofysiologiForenede Stater
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Dana-Farber Cancer InstituteAfsluttet
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Azienda Ospedaliera Universitaria Integrata VeronaAfsluttet
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Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)Aktiv, ikke rekrutterendeSlag | Afasi | Afasi ikke flydendeForenede Stater