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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Victoria
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Parkville, Victoria, Australië, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australië, 6001
- Princess Margaret Hospital for Children
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- University of Arkansas for Medical Sciences
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California
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La Jolla, California, Verenigde Staten, 92093-0658
- University of California San Diego Cancer Center
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Los Angeles, California, Verenigde Staten, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Verenigde Staten, 91010
- Beckman Research Institute, City of Hope
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Los Angeles, California, Verenigde Staten, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, Verenigde Staten, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Verenigde Staten, 94304
- Lucile Packard Children's Hospital at Stanford
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San Francisco, California, Verenigde Staten, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20010-2970
- Children's National Medical Center
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Florida
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Gainesville, Florida, Verenigde Staten, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, Verenigde Staten, 60614
- Children's Memorial Hospital, Chicago
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202-5265
- Indiana University Cancer Center
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21231
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Verenigde Staten, 02111
- Boston Floating Hospital Infants and Children
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- Mott Children's Hospital
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Detroit, Michigan, Verenigde Staten, 48201
- Children's Hospital of Michigan
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Verenigde Staten, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, Verenigde Staten, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Verenigde Staten, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Verenigde Staten, 10032
- Columbia Presbyterian Hospital
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Syracuse, New York, Verenigde Staten, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38105-2794
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, Verenigde Staten, 37232-6838
- Vanderbilt Cancer Center
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Texas
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Fort Worth, Texas, Verenigde Staten, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Verenigde Staten, 77030
- Baylor College of Medicine
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Houston, Texas, Verenigde Staten, 77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Verenigde Staten, 78284-7811
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84132
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Verenigde Staten, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53792-0001
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Midwest Children's Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
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Andere namen:
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Experimenteel: ECTEINASCIDIN 743 (1300 ug/m2)
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Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Progressievrije overleving
Tijdsspanne: Duur van de studie
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Duur van de studie
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Dose Limiting Toxicity
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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.
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Determine a safe and tolerable dose of vincristine, when administered with irinotecan
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To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
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Determine the pharmacokinetics of vincristine and irinotecan
Tijdsspanne: Length of study
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To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
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Length of study
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Determine the incidence and severity of other toxicities
Tijdsspanne: Length of study
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To determine the incidence and severity of other toxicities of this combination.
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Length of study
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Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine
Tijdsspanne: Length of study
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To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
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Length of study
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Sylvain Baruchel, MD, The Hospital for Sick Children
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P9972
- COG-P9972 (Andere identificatie: Children's Oncology Group)
- POG-P9972 (Andere identificatie: Pediatric Oncology Group)
- CDR0000068273 (Andere identificatie: Clinical Trials.gov)
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