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Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

16. september 2014 oppdatert av: Children's Oncology Group

A Phase II Study of Irinotecan + Temozolomide in Children With Recurrent Neuroblastoma

RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Determine the response rate in pediatric patients with relapsed neuroblastoma (NB) treated with irinotecan hydrochloride and temozolomide.
  • Determine the toxicities associated with irinotecan and temozolomide in patients treated with this regimen.

Secondary

  • Evaluate the impact of p53 loss of function on response rate and event-free survival from start of relapse therapy.
  • Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients.
  • Collect and bank serum and nucleic acid specimen to facilitate future biomarker studies.
  • Evaluate the feasibility of collecting blood samples on a group wide basis for assessment of changes in circulating markers of angiogenesis.
  • Assess, preliminarily, the effects of irinotecan hydrochloride and temozolomide on circulating markers of angiogenesis.

OUTLINE: This is a multicenter study.

Patients are stratified according to disease status (measurable disease [measured by conventional CT scan and/or MRI] vs evaluable disease [tumor detected by conventional morphologic analysis of bone marrow aspirate/biopsy AND/OR abnormal uptake at ≥ 1 site on MIBG scan]).

Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral temozolomide on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

59

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2310
        • John Hunter Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Institute for Cancer Research at Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Children's Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 4G5
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • Arizona
      • Tucson, Arizona, Forente stater, 85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, Forente stater, 90242-2814
        • Southern California Permanente Medical Group
      • Loma Linda, California, Forente stater, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Forente stater, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, Forente stater, 90027
        • Childrens Hospital Los Angeles
      • Madera, California, Forente stater, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Forente stater, 94609
        • Children's Hospital and Research Center Oakland
      • Orange, California, Forente stater, 92868
        • Children's Hospital of Orange County
      • Sacramento, California, Forente stater, 95816
        • Sutter Cancer center
      • Sacramento, California, Forente stater, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Francisco, California, Forente stater, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • Stanford, California, Forente stater, 94305-5824
        • Stanford Cancer Center
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Children's Hospital Center for Cancer and Blood Disorders
    • Connecticut
      • Farmington, Connecticut, Forente stater, 06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • Delaware
      • Wilmington, Delaware, Forente stater, 19803
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Myers, Florida, Forente stater, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, Forente stater, 32610-0232
        • University of Florida Shands Cancer Center
      • Jacksonville, Florida, Forente stater, 32207
        • Nemours Children's Clinic
      • Miami, Florida, Forente stater, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
      • Miami, Florida, Forente stater, 33155
        • Miami Children's Hospital
      • Orlando, Florida, Forente stater, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Pensacola, Florida, Forente stater, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • St. Petersburg, Florida, Forente stater, 33701
        • All Children's Hospital
      • Tampa, Florida, Forente stater, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, Forente stater, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Winship Cancer Institute of Emory University
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Boise, Idaho, Forente stater, 83712-6297
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forente stater, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, Forente stater, 60614
        • Children's Memorial Hospital - Chicago
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
    • Iowa
      • Des Moines, Iowa, Forente stater, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, Forente stater, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
      • Louisville, Kentucky, Forente stater, 40232
        • Kosair Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70118
        • Children's Hospital of New Orleans
    • Maryland
      • Baltimore, Maryland, Forente stater, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Forente stater, 02111
        • Floating Hospital for Children at Tufts - New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0286
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Detroit, Michigan, Forente stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, Forente stater, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Forente stater, 49503-2560
        • Butterworth Hospital at Spectrum Health
      • Grosse Pointe Woods, Michigan, Forente stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, Forente stater, 49007-5341
        • CCOP - Kalamazoo
      • Lansing, Michigan, Forente stater, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Minneapolis, Minnesota, Forente stater, 55455
        • Masonic Cancer Center at University of Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216-4505
        • University of Mississippi Cancer Clinic
    • Missouri
      • Kansas City, Missouri, Forente stater, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, Forente stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114-4113
        • Children's Hospital
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89109-2306
        • Sunrise Hospital and Medical Center
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center Cancer Center
      • Morristown, New Jersey, Forente stater, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, Forente stater, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, Forente stater, 07112
        • Newark Beth Israel Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87131-5636
        • University of New Mexico Cancer Center
    • New York
      • Bronx, New York, Forente stater, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, Forente stater, 11219
        • Maimonides Cancer Center at Maimonides Medical Center
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, Forente stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Rochester, New York, Forente stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, Forente stater, 11794-9446
        • Stony Brook University Cancer Center
      • Syracuse, New York, Forente stater, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, Forente stater, 10595
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, Forente stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Forente stater, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, Forente stater, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Akron, Ohio, Forente stater, 44308-1062
        • Akron Children's Hospital
      • Cincinnati, Ohio, Forente stater, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forente stater, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Columbus, Ohio, Forente stater, 43205-2696
        • Nationwide Children's Hospital
      • Dayton, Ohio, Forente stater, 45404-1815
        • Children's Medical Center - Dayton
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forente stater, 18107
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, Forente stater, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Hershey, Pennsylvania, Forente stater, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forente stater, 19134-1095
        • St. Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, Forente stater, 19104-9786
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Children's Hospital of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, Forente stater, 29203
        • Palmetto Health South Carolina Cancer Center
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37901
        • East Tennessee Children's Hospital
      • Nashville, Tennessee, Forente stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Austin, Texas, Forente stater, 78723
        • Dell Children's Medical Center of Central Texas
      • Corpus Christi, Texas, Forente stater, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, Forente stater, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, Forente stater, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, Forente stater, 76104
        • Cook Children's Medical Center - Fort Worth
      • Houston, Texas, Forente stater, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Lubbock, Texas, Forente stater, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Forente stater, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, Forente stater, 78207
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, Forente stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Norfolk, Virginia, Forente stater, 23507-1971
        • Children's Hospital of the King's Daughters
      • Richmond, Virginia, Forente stater, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
    • Washington
      • Seattle, Washington, Forente stater, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Spokane, Washington, Forente stater, 99220-2555
        • Providence Cancer Center at Sacred Heart Medical Center
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25302
        • West Virginia University Health Sciences Center - Charleston
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Midwest Children's Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 21 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines at initial diagnosis

    • Patients with elevated catecholamines only are not eligible

  • Meets 1 of the following criteria:

    • Recurrent disease following aggressive, multidrug, frontline chemotherapy, defined as chemotherapy given with ≥ 2 agents, including an alkylating agent and a platinum-containing compound
    • Resistant/refractory disease during aggressive, multidrug, frontline chemotherapy

  • Must meet 1 of the following criteria for documentation of disease:

    • Unidimensionally measurable tumor ≥ 20 mm by MRI (Magnetic Resonance Imaging), CT scan (Computed Tomography), or x-ray OR ≥ 10 mm by spiral CT scan within 4 weeks prior to study entry

      • Patients with residual stable tumor upon completion of frontline therapy must undergo biopsy to document presence of a viable neuroblastoma
      • If the measurable target lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma

    • MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical) with positive uptake at ≥ 1 site within 4 weeks prior to study entry

      • Patients with residual stable MIBG-positive lesions upon completion of frontline therapy must undergo biopsy to document presence of viable neuroblastoma
      • If the patient has only 1 MIBG-positive lesion, and that lesion was previously radiated, a biopsy must be performed ≥ 4 weeks after radiation was completed AND the biopsy must demonstrate viable neuroblastoma
    • Bone marrow with tumor cells on routine morphology (not by neuron-specific enolase staining only) of bilateral aspirate and/or biopsy on 1 bone marrow sample within 2 weeks prior to study entry
  • No extensive marrow disease
  • No myelodysplastic syndrome

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
  • Life expectancy ≥ 8 weeks
  • Absolute neutrophil count ≥ 750/mm^3
  • Platelet count ≥ 75,000/mm^3 (transfusion independent)
  • Hemoglobin ≥ 8.5 mg/dL (transfusion allowed)

  • Creatinine adjusted according to age as follows:

    • No greater than 0.4 mg/dL (≤ 5 months)
    • No greater than 0.5 mg/dL (6 months -11 months)
    • No greater than 0.6 mg/dL (1 year-23 months)
    • No greater than 0.8 mg/dL (2 years-5 years)
    • No greater than 1.0 mg/dL (6 years-9 years)
    • No greater than 1.2 mg/dL (10 years-12 years)
    • No greater than 1.4 mg/dL (13 years and over [female])
    • No greater than 1.5 mg/dL (13 years to 15 years [male])
    • No greater than 1.7 mg/dL (16 years and over [male]) OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • ALT < 2.5 times ULN for age
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Seizure disorder allowed provided seizures are well controlled on non-EIAC medication
  • No active diarrhea or uncontrolled infection
  • No other malignancy, including secondary malignancy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior front-line therapy (e.g., surgery, chemotherapy, immunotherapy, radiotherapy, or retinoids) allowed
  • Recovered from prior therapy
  • More than 4 weeks since prior radiation therapy to the site of any lesion that will be identified as a target lesion to measure tumor response
  • At least 2 weeks since prior myelosuppressive therapy (4 weeks for nitrosourea)
  • At least 1 week since prior therapy with an antineoplastic biologic agent or retinoid
  • At least 1 week since prior growth factors
  • At least 1 week since prior and no other concurrent anticancer agents

  • At least 1 week since prior and no concurrent enzyme-inducing anticonvulsants (EIAC), including phenytoin, phenobarbital, valproic acid, or carbamazepine

    • Concurrent gabapentin or levetiracetam allowed
  • Concurrent palliative radiation therapy to sites not used to measure tumor response allowed

  • No prior allogeneic stem cell transplantation (SCT)

    • Prior autologous SCT allowed
  • No prior second-line chemotherapy for relapsed or refractory disease

  • No concurrent immunomodulating agents

    • Concurrent steroids for transfusion/infusion reactions or for treatment of edema associated with CNS lesions allowed

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Disease measurable by CT or MRI scan (Irinotecan/Temozolomide)
Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Legemiddel: irinotekanhydroklorid
Gitt IV
Andre navn:
  • CPT-11
  • NSC #616348
Legemiddel: temozolomide
Given IV
Andre navn:
  • TEMODAR
  • NSC #362856
Eksperimentell: Disease eval by bone marrow or MIBG (Irinotecan/Temozolomide)
Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Legemiddel: irinotekanhydroklorid
Gitt IV
Andre navn:
  • CPT-11
  • NSC #616348
Legemiddel: temozolomide
Given IV
Andre navn:
  • TEMODAR
  • NSC #362856

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Tidsramme: up to 6 courses of therapy, or about 6 months
The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as "best response". Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).
up to 6 courses of therapy, or about 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Rochelle Bagatell, MD, University of Arizona

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2006

Primær fullføring (Faktiske)

1. mars 2009

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

5. april 2006

Først innsendt som oppfylte QC-kriteriene

5. april 2006

Først lagt ut (Anslag)

6. april 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2014

Sist bekreftet

1. september 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ANBL0421
  • CDR0000465487 (Annen identifikator: Clinical Trials.gov)
  • COG-ANBL0421 (Annen identifikator: Children's Oncology Group)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Nevroblastom

Kliniske studier på irinotekanhydroklorid

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Norway

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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