- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00014092
Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine the response rate, time to progression, and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim (GM-CSF), interleukin-2, and interferon alfa.
- Determine the safety and tolerability of this regimen in this patient population.
- Determine the changes in quality of life over time in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.
Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.
Tipo de estudo
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94109
- Saint Francis Memorial Hospital
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Santa Monica, California, Estados Unidos, 90404
- John Wayne Cancer Institute at Saint John's Health Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences 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 unresectable stage IV melanoma
- Measurable metastatic disease
- No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
Renal:
- BUN no greater than 1.5 times ULN
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No significant cardiovascular disease
Other:
- No non-malignant systemic disease
- No acute infection requiring IV antibiotics
- No alcohol or substance abuse
- No other condition, disease, or history of other illness that would preclude study participation
- No hypersensitivity, allergic reactions, or intolerance to study drugs
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No prior interleukin-2
- No other concurrent immunotherapy
- No concurrent investigational vaccines or immunomodulatory agents
- No other concurrent growth factors
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No prior temozolomide
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- No concurrent steroids (including corticosteroids)
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior major surgery
Other:
- At least 30 days since prior immune-based therapy
- No concurrent participation in other clinical trials with investigational drugs
- No other concurrent anticancer drugs
- No concurrent immunosuppressive therapy
- No concurrent levamisole or cimetidine
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Lynn E. Spitler, MD, Northern California Melanoma Center at St. Francis Memorial Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
- Neoplasias por Tipo Histológico
- Neoplasias
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Tumores Neuroendócrinos
- Nevos e Melanomas
- Melanoma
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Agentes anti-HIV
- Antirretrovirais
- Agentes Antineoplásicos
- Fatores imunológicos
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Interferons
- Interferon-alfa
- Aldesleucina
- Temozolomida
- Sargramostim
Outros números de identificação do estudo
- CDR0000067958
- SFMH-BB-IND-5301
- NCI-V00-1591
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 .