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- Ensaio Clínico NCT00458744
Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment
A Phase I Study Of Talotrexin (PT-523) In Children And Adolescents With Recurrent Solid Tumors Or Recurrent/Refractory Leukemias
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of talotrexin in treating young patients with recurrent solid tumors or leukemia that is recurrent or does not respond to treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose (MTD) and recommended phase II dose of talotrexin in younger patients with recurrent solid tumors or recurrent or refractory leukemia.
- Determine the toxicity of this drug in these patients.
Secondary
- Determine the antitumor activity of this drug in these patients.
- Assess the tolerability of the defined MTD of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (solid tumor vs leukemia).
- Stratum 1 (recurrent solid tumor): Patients receive talotrexin IV over 10 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of talotrexin 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 toxicity (DLT).
- Stratum 2 (recurrent or refractory leukemia): A cohort of 3-6 patients with leukemia receive treatment as in stratum 1 at the MTD determined in stratum 1. If 2 or 3 or 2 of 6 patients experience a DLT at the solid tumor MTD, accrual is stopped.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Tipo de estudo
Estágio
- Fase 1
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Diagnosis of either of the following:
Recurrent solid tumor
- Histologically confirmed* malignancy at original diagnosis or relapse
- Measurable or evaluable disease
Lymphoma or primary CNS tumor allowed
- Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for the past 7 days
Recurrent or refractory leukemia
- Confirmed relapse, as defined by M3 marrow (25% blasts in bone marrow aspirate or biopsy)
- Active extramedullary disease allowed provided there is no leptomeningeal involvement NOTE: *Histological confirmation not required for intrinsic brain stem tumors
Bone marrow metastases allowed
- Not refractory to red blood cell or platelet transfusion
- No pleural effusion or significant ascites
- No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
- No Down syndrome
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% (for patients > 10 years of age) OR Lansky PS 50-100% (for patients ≤ 10 years of age)
- Absolute neutrophil count ≥ 1,000/mm³ (for patients with solid tumors without bone marrow involvement)
- Platelet count ≥ 100,000/mm³ (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine adjusted according to age as follows:
- No greater than 0.6 mg/dL (1 year to 23 months)
- No greater than 0.8 mg/dL (2 to 5 years)
- No greater than 1.0 mg/dL (6 to 9 years)
- No greater than 1.2 mg/dL (10 to 12 years)
- No greater than 1.4 mg/dL (13 years and over [female])
- No greater than 1.5 mg/dL (13 to 15 years [male])
- No greater than 1.7 mg/dL (16 years and over [male])
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 110 U/L (ULN is 45 U/L)
- Albumin ≥ 2 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No known condition that, in the opinion of the investigator, would preclude study compliance
PRIOR CONCURRENT THERAPY:
- Recovered from all prior treatment-related toxicity
- At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) (for patients with solid tumors)
- At least 24 hours since prior cytoreduction therapy initiated with hydroxyurea (for patients with leukemia)
- At least 2 weeks since prior local palliative radiotherapy (small port)
- At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or ≥ 50% radiotherapy to the pelvis
- At least 6 weeks since prior substantial bone marrow radiotherapy
At least 3 months since prior stem cell transplant or rescue without TBI
- No evidence of active graft-versus-host disease
- At least 7 days since prior growth factor therapy
- At least 7 days since prior biological therapy
- No nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, penicillins, sulfa drugs (bactrim, septra), ciprofloxacin, tetracycline, thiazide diuretics, or probenecid within 2 days prior to, during, or within 5 days after treatment with talotrexin
- No long-acting NSAIDs (e.g., nabumetone, naproxen, oxaprozin, piroxicam) within 5 days prior to, during, or within 5 days after treatment with talotrexin
- No concurrent investigational drugs
- No concurrent anticancer agents or therapy (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
---|
Toxicidade
|
Maximum tolerated dose of talotrexin
|
Medidas de resultados secundários
Medida de resultado |
---|
Tolerabilidade
|
Atividade antitumoral
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: James Croop, MD, PhD, Riley's Children Cancer Center at Riley Hospital for Children
- Cadeira de estudo: Sultan Ahmed Pradhan, MD, Tata Memorial Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
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
- tumor sólido infantil não especificado, protocolo específico
- linfoma de pequenas células não clivadas estágio IV da infância
- linfoma de grandes células da infância estágio IV
- linfoma infantil recorrente de pequenas células não clivadas
- linfoma de grandes células da infância recorrente
- leucemia mielomonocítica juvenil
- Leucemia Mielóide Crônica na Infância
- linfoma de Hodgkin infantil recorrente/refratário
- leucemia mielóide crônica recidivante
- leucemia linfoblástica aguda recorrente na infância
- linfoma linfoblástico infantil estágio IV
- ependimoma infratentorial da infância
- linfoma de Hodgkin na infância estágio IV
- leucemia mielóide aguda recorrente na infância
- linfoma linfoblástico infantil recorrente
- leucemia promielocítica aguda da infância (M3)
- granulomatose linfomatóide grau III na infância
- granulomatose linfomatóide grau III recorrente na infância
- ependimoma supratentorial infantil
- astrocitoma cerebelar infantil recorrente
- astrocitoma cerebral infantil recorrente
- ependimoma infantil recorrente
- tumor cerebral infantil recorrente
- glioma do tronco cerebral recorrente na infância
- meduloblastoma infantil recorrente
- Via visual infantil recorrente e glioma hipotalâmico
- craniofaringioma infantil
- tumor de células germinativas do sistema nervoso central na infância
- tumor do plexo coróide na infância
- meningioma grau I da infância
- meningioma grau II da infância
- meningioma grau III da infância
- linfoma extranodal de células NK/T do tipo nasal infantil
- glioma recorrente da via visual na infância
- pineoblastoma infantil recorrente
- recurrent childhood supratentorial primitive neuroectodermal tumors
- high-grade childhood cerebral astrocytoma
- low-grade childhood cerebral astrocytoma
- childhood spinal cord tumor
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças do Sistema Nervoso
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Neoplasias por local
- Atributos da doença
- Neoplasias
- Linfoma
- Leucemia
- Recorrência
- Neoplasias do Sistema Nervoso
- Neoplasias do Sistema Nervoso Central
Outros números de identificação do estudo
- ADVL0613
- COG-ADVL0613 (Outro identificador: Children's Oncology Group)
- CDR0000538359 (Outro identificador: Clinical Trials.gov)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .