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Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma

16. září 2014 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

59

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Ne starší než 21 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: irinotekan hydrochlorid
Vzhledem k tomu, IV
Ostatní jména:
  • CPT-11
  • NSC #616348
Lék: temozolomide
Given IV
Ostatní jména:
  • TEMODAR
  • NSC #362856
Experimentální: 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.
Lék: irinotekan hydrochlorid
Vzhledem k tomu, IV
Ostatní jména:
  • CPT-11
  • NSC #616348
Lék: temozolomide
Given IV
Ostatní jména:
  • TEMODAR
  • NSC #362856

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Children's Oncology Group

Spolupracovníci

National Cancer Institute (NCI)

Vyšetřovatelé

  • Studijní židle: Rochelle Bagatell, MD, University of Arizona

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2006

Primární dokončení (Aktuální)

1. března 2009

Dokončení studie (Aktuální)

1. prosince 2013

Termíny zápisu do studia

První předloženo

5. dubna 2006

První předloženo, které splnilo kritéria kontroly kvality

5. dubna 2006

První zveřejněno (Odhad)

6. dubna 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

30. září 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. září 2014

Naposledy ověřeno

1. září 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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