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- Ensaio Clínico NCT00014248
Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
A Phase I Study And Pharmacokinetics Of Adenosine 5'- Triphosphate (ATP) When Administered By Intravenous Infusion On A Multiple Weekly Dose Schedule To Patients With Advanced Malignancies (Solid Tumors)
RATIONALE: Adenosine triphosphate may decrease weight loss and improve muscle strength in patients with advanced solid tumors.
PURPOSE: Phase I trial to study the effectiveness of adenosine triphosphate in controlling loss of weight and loss of muscle mass in patients who have advanced solid tumors.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine the individualized maximum tolerated dose of adenosine triphosphate in patients with advanced solid tumors.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the effect of this regimen on quality of life of these patients.
- Determine the influence of this regimen on cancer cachexia in terms of weight change, percentage of body fat, voluntary muscle strength, and plasma markers in these patients.
- Determine the effect of this regimen on tumor burden in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive adenosine triphosphate (ATP) IV over 8 hours on day 0. Treatment repeats weekly for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Each patient receives escalating doses of ATP until the individual maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which the patient experiences at least grade 3 (at least grade 2 cardiac ischemia or arrhythmia) toxicity.
Weight is measured at baseline and at weeks 1-8, 10, and 13. Percentage of body fat and skeletal muscle strength is measured at baseline and at weeks 2, 4, 8, 10, and 13.
Quality of life is assessed at baseline and at weeks 2, 4, 8, 10, and 13.
Patients are followed at weeks 10 and 13.
PROJECTED ACCRUAL: A maximum of 13-24 patients will be accrued for this study.
Tipo de estudo
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756-0002
- Norris Cotton 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 or cytologically confirmed advanced solid tumor that is not curable by conventional therapy
- Brain metastases allowed if adequately controlled with radiotherapy
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 3,500/mm^3
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGOT and SGPT no greater than 3 times normal
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
- BUN no greater than 25 mg/dL
Cardiovascular:
- Adequate cardiovascular function
- No congestive heart failure (New York Heart Association class III or IV heart disease)
- No angina pectoris AND/OR
- No significant arrhythmia
- No myocardial infarction within the past 6 months
- No clinically significant ischemic cardiac disease currently under treatment
- No clinically significant conduction system disease in the absence of a pacemaker (e.g., sick sinus syndrome, or second or third degree atrioventricular block)
Pulmonary:
- Adequate pulmonary function
- No clinical evidence of acute chronic obstructive pulmonary disease
- FEV1 at least 50% predicted
- Arterial oxygen tension at least 90% by pulse oximetry and on breathing room air
- No asthma OR
- No evidence of more than 20% reversibility in FEV1 with albuterol therapy
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of severe adverse reaction to adenosine
- No uncontrolled medical illness
- No average daily pain scores of at least 5 on a simple Visual Analogue Self pain assessment (0-10) scale
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- At least 30 days since prior investigational therapy
- At least 14 days since prior long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy
- No concurrent long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy
- No concurrent maintenance anti-anginal drug therapy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Lionel D. Lewis, MD, Norris Cotton Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (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
Termos MeSH relevantes adicionais
- Doenças Metabólicas
- Distúrbios Nutricionais
- Peso corporal
- Alterações de Peso Corporal
- Emagrecimento
- Perda de peso
- Síndrome de Desperdício
- Caquexia
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antiarrítmicos
- Agentes Vasodilatadores
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes Purinérgicos
- Agonistas Purinérgicos do Receptor P1
- Agonistas Purinérgicos
- Adenosina
Outros números de identificação do estudo
- CDR0000068522
- DMS-0005
- ATP-DMS-0005
- NCI-G01-1923
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