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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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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, Canadá, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canadá, H3H 1P3
- Montreal Children's Hospital
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Montreal, Quebec, Canadá, H3T 1C5
- Hôpital Sainte Justine
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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California
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La Jolla, California, Estados Unidos, 92093-0658
- University of California San Diego Cancer Center
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Estados Unidos, 91010
- Beckman Research Institute, City of Hope
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Los Angeles, California, Estados Unidos, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Children's Hospital at Stanford
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San Francisco, California, Estados Unidos, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Florida
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Gainesville, Florida, Estados Unidos, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital, Chicago
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5265
- Indiana University Cancer Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02111
- Boston Floating Hospital Infants and Children
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Mott Children's Hospital
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Detroit, Michigan, Estados Unidos, 48201
- Children's Hospital of Michigan
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10032
- Columbia Presbyterian Hospital
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Syracuse, New York, Estados Unidos, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105-2794
- Saint Jude Children's Research Hospital
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Nashville, Tennessee, Estados Unidos, 37232-6838
- Vanderbilt Cancer Center
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Texas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Estados Unidos, 78284-7811
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792-0001
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
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Otros nombres:
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Experimental: ECTEINASCIDIN 743 (1300 ug/m2)
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Supervivencia libre de progresión
Periodo de tiempo: Duración de los estudios
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Duración de los estudios
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Sylvain Baruchel, MD, The Hospital for Sick Children
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P9972
- COG-P9972 (Otro identificador: Children's Oncology Group)
- POG-P9972 (Otro identificador: Pediatric Oncology Group)
- CDR0000068273 (Otro identificador: Clinical Trials.gov)
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