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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Ontario
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Toronto, Ontario, Kanada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- Montreal Children's Hospital
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Montreal, Quebec, Kanada, H3T 1C5
- Hôpital Sainte Justine
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- University of Arkansas for Medical Sciences
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California
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La Jolla, California, Stany Zjednoczone, 92093-0658
- University of California San Diego Cancer Center
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Los Angeles, California, Stany Zjednoczone, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Stany Zjednoczone, 91010
- Beckman Research Institute, City of Hope
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Los Angeles, California, Stany Zjednoczone, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, Stany Zjednoczone, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Stany Zjednoczone, 94304
- Lucile Packard Children's Hospital at Stanford
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San Francisco, California, Stany Zjednoczone, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington, District of Columbia, Stany Zjednoczone, 20010-2970
- Children's National Medical Center
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60614
- Children's Memorial Hospital, Chicago
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202-5265
- Indiana University Cancer Center
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21231
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Boston Floating Hospital Infants and Children
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- Mott Children's Hospital
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Detroit, Michigan, Stany Zjednoczone, 48201
- Children's Hospital of Michigan
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Minnesota
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Stany Zjednoczone, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Stany Zjednoczone, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, Stany Zjednoczone, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Stany Zjednoczone, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Stany Zjednoczone, 10032
- Columbia Presbyterian Hospital
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Syracuse, New York, Stany Zjednoczone, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Stany Zjednoczone, 38105-2794
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, Stany Zjednoczone, 37232-6838
- Vanderbilt Cancer Center
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Texas
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Fort Worth, Texas, Stany Zjednoczone, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Stany Zjednoczone, 77030
- Baylor College of Medicine
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Houston, Texas, Stany Zjednoczone, 77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Stany Zjednoczone, 78284-7811
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84132
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Stany Zjednoczone, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, Stany Zjednoczone, 53792-0001
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Midwest Children's Cancer Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
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Inne nazwy:
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Eksperymentalny: ECTEINASCIDIN 743 (1300 ug/m2)
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Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Przetrwanie bez progresji
Ramy czasowe: Długość studiów
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Długość studiów
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Sylvain Baruchel, MD, The Hospital for Sick Children
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P9972
- COG-P9972 (Inny identyfikator: Children's Oncology Group)
- POG-P9972 (Inny identyfikator: Pediatric Oncology Group)
- CDR0000068273 (Inny identyfikator: Clinical Trials.gov)
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