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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Victoria
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Parkville, Victoria, Austrália, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Austrália, 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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
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Outros nomes:
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Experimental: ECTEINASCIDIN 743 (1300 ug/m2)
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Sobrevivência Livre de Progressão
Prazo: Duração do estudo
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Duração do estudo
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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
Prazo: 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
Prazo: 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
- Cadeira de estudo: Sylvain Baruchel, MD, The Hospital for Sick Children
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P9972
- COG-P9972 (Outro identificador: Children's Oncology Group)
- POG-P9972 (Outro identificador: Pediatric Oncology Group)
- CDR0000068273 (Outro identificador: Clinical Trials.gov)
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