- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00006463
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Victoria
-
Parkville, Victoria, Australien, 3052
- Royal Children's Hospital
-
-
Western Australia
-
Perth, Western Australia, Australien, 6001
- Princess Margaret Hospital for Children
-
-
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
-
-
Quebec
-
Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital
-
Montreal, Quebec, Canada, H3T 1C5
- Hopital Sainte Justine
-
-
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
-
-
California
-
La Jolla, California, Forenede Stater, 92093-0658
- University of California San Diego Cancer Center
-
Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles, California, Forenede Stater, 91010
- Beckman Research Institute, City of Hope
-
Los Angeles, California, Forenede Stater, 90027-0700
- Children's Hospital Los Angeles
-
Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
-
Palo Alto, California, Forenede Stater, 94304
- Lucile Packard Children's Hospital at Stanford
-
San Francisco, California, Forenede Stater, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32610-100277
- Shands Hospital and Clinics, University of Florida
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital - Atlanta
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60614
- Children's Memorial Hospital, Chicago
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202-5265
- Indiana University Cancer Center
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21231
- Johns Hopkins Oncology Center
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02111
- Boston Floating Hospital Infants and Children
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- Mott Children's Hospital
-
Detroit, Michigan, Forenede Stater, 48201
- Children's Hospital of Michigan
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
-
Saint Louis, Missouri, Forenede Stater, 63104
- Cardinal Glennon Children's Hospital
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
-
New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forenede Stater, 10032
- Columbia Presbyterian Hospital
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York - Upstate Medical University
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Duke Comprehensive Cancer Center
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45229-3039
- Children's Hospital Medical Center - Cincinnati
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425-0721
- Medical University of South Carolina
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38105-2794
- Saint Jude Children's Research Hospital
-
Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt Cancer Center
-
-
Texas
-
Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
-
Houston, Texas, Forenede Stater, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
San Antonio, Texas, Forenede Stater, 78284-7811
- University of Texas Health Science Center at San Antonio
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84132
- Huntsman Cancer Institute
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792-0001
- University of Wisconsin Hospital and Clinics
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Midwest Children's Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor at original diagnosis Refractory to standard treatment or no curative therapy available No CNS tumor No bone marrow metastases (for less heavily pretreated stratum only)
PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky 50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT no greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Creatine phosphokinase less than 2 times normal No uncontrolled infection Seizure disorder allowed if well controlled on anticonvulsants No CNS toxicity greater than grade II
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy and recovered At least 1 week since prior growth factor therapy At least 6 months since prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated stratum: No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis For less heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater No prior irradiation to greater than 50% of pelvis Recovered from toxic effects of prior radiotherapy Surgery: Not specified Other: No concurrent foods or medication that interferes with P-450 metabolism Anticonvulsants 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 |
---|---|
Eksperimentel: Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
|
Andre navne:
|
Eksperimentel: ECTEINASCIDIN 743 (1300 ug/m2)
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progressionsfri overlevelse
Tidsramme: Studielængde
|
Studielængde
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Dose Limiting Toxicity
|
To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.
|
|
Determine a safe and tolerable dose of vincristine, when administered with irinotecan
|
To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
|
|
Determine the pharmacokinetics of vincristine and irinotecan
Tidsramme: Length of study
|
To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
|
Length of study
|
Determine the incidence and severity of other toxicities
Tidsramme: Length of study
|
To determine the incidence and severity of other toxicities of this combination.
|
Length of study
|
Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine
Tidsramme: Length of study
|
To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
|
Length of study
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Sylvain Baruchel, MD, The Hospital for Sick Children
Publikationer og nyttige links
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P9972
- COG-P9972 (Anden identifikator: Children's Oncology Group)
- POG-P9972 (Anden identifikator: Pediatric Oncology Group)
- CDR0000068273 (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 Uspecificeret fast tumor i barndommen, protokolspecifik
-
City of Hope Medical CenterAktiv, ikke rekrutterendeUspecificeret fast tumor i barndommen, protokolspecifik | Solid tumor | Ewing Sarkom | Uspecificeret fast tumor hos voksne, protokolspecifik | Tilbagevendende medulloblastom i barndommen | Tilbagevendende Childhood Ependymoma | Tilbagevendende neuroblastom | Tilbagevendende bløddelssarkom hos voksne | Tilbagevendende... og andre forholdForenede Stater
Kliniske forsøg med ECTEINASCIDIN 743
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Janssen PharmaceuticalsTrukket tilbageMyxoid liposarkom | Stage III blødt vævssarkom AJCC v7 | Stage IV blødt vævssarkom AJCC v7 | Rundcellet liposarkom | Uopretteligt blødt vævssarkom | Metastatisk blødt vævssarkomForenede Stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Trukket tilbageRefraktær kronisk lymfatisk leukæmi | Refraktært lille lymfocytisk lymfomForenede Stater
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); EMD SeronoAfsluttetMetastatisk Leiomyosarkom | Ikke-operabelt Leiomyosarcoma | Metastatisk liposarkom | Uoperabelt liposarkomForenede Stater
-
Children's Oncology GroupNational Cancer Institute (NCI)AfsluttetTilbagevendende Ewing-sarkom | Tilbagevendende rhabdomyosarkom i barndommen | Tidligere behandlet Childhood Rhabdomyosarcoma | Tilbagevendende bløddelssarkom i barndommen | Perifer primitiv neuroektodermal tumorForenede Stater, Canada
-
Yale UniversityEdison Pharmaceuticals Inc; Rembrandt FoundationAfsluttet
-
Edison Pharmaceuticals IncAfsluttet
-
TakedaTakeda Development Center Americas, Inc.Afsluttet
-
TakedaRekruttering
-
PTC TherapeuticsAfsluttetMitokondrielle sygdomme | Lægemiddelresistent epilepsi | Leighs sygdom | Leigh syndrom | Mitokondriel encefalopati (MELAS) | Pontocerebellar Hypoplasi Type 6 (PCH6) | Alpers sygdom | Alpers syndromForenede Stater, Spanien, Det Forenede Kongerige, Canada, Frankrig, Italien, Polen, Sverige, Japan
-
TakedaAfsluttet