Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
PHASE II TRIAL OF R115777 IN PATIENTS WITH METASTATIC MALIGNANT MELANOMA
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
PRIMARY OBJECTIVES:
I. To estimate the clinical response rate in patients with metastatic malignant melanoma treated with R115777 (tipifarnib).
II. To evaluate the safety of R115777 in patients with metastatic melanoma.
SECONDARY OBJECTIVES:
I. To assess RhoC expression in tumor samples pre- and post- therapy with R115777.
II. To evaluate Ftase levels in peripheral blood and tumor samples pre- and post-therapy with R115777.
III. To assess the effect of R115777 treatment on T lymphocyte cytokine production, pre- and post- therapy with R115777.
IV. Estimate time to treatment failure (TTF). Time to treatment failure is defined as time to withdrawal for unacceptable toxicity or progressive disease.
OUTLINE Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.
Patients who discontinue therapy due to toxicity or complete response are followed every 3 months for 2 years after study entry. Patients who discontinue therapy due to disease progression are followed every 6 months for 2 years after study entry. Patients with stable or partially responding disease who complete treatment are followed at 2 years after study entry.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Illinois
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Chicago, Illinois, Estados Unidos, 60606
- Cancer and Leukemia Group B
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
Patients must have at least 2 cutaneous lesions amenable to excisional biopsy for correlative studies; in addition, patients must have measurable disease; the disease remaining after the first excisional biopsy must be measurable; lesions that are considered intrinsically non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Lesions that are situated in a previously irradiated area
- No history of brain metastases
- No allergies to azoles (e.g. ketoconazole) or allergies to compounds structurally similar to R115777
No more than 1 prior immunotherapy regimen for treatment of advanced melanoma; an additional immunologic therapy in the adjuvant setting (e.g. IFN-a) is acceptable; prior chemotherapy for any stage of melanoma is not allowed
- No radiotherapy or immunotherapy within four weeks prior to the initiation of therapy on this study
- CTC (ECOG) performance status 0-1
- Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control; women of child-bearing age will undergo pregnancy testing
- ANC >= 1500/uL
- Platelets >= 100,000/uL
- Bilirubin =< 1.5 mg/dL
- Creatinine =< 2.0 mg/dL
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: Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21.
Treatment repeats every 28 days for at least 2 courses and for a maximum of 2 years in the absence of disease progression or unacceptable toxicity.
Patients who achieve CR receive 2 additional courses beyond CR.
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Estudos correlativos
Dado oralmente
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Response rate (complete response [CR] and partial response [PR]}
Prazo: Up to 2 years
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Estimated confidence intervals will be adjusted for the number of stages.
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Up to 2 years
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Progression-free survival (PFS)
Prazo: From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years
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Estimated using the method of Kaplan and Meier.
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From date of entry onto the trial until documented progression or death from any cause, assessed up to 2 years
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Time to treatment failure (TTF)
Prazo: From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years
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Estimated using the method of Kaplan and Meier.
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From trial entry until a patient ends protocol therapy due to unacceptable toxicity, progression or death from any cause, assessed up to 2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Correlation between RhoC expression levels and response
Prazo: From baseline to up to 2 years
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From baseline to up to 2 years
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Change in FTAse levels
Prazo: From baseline to up to 2 years
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From baseline to up to 2 years
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Change in the production of IL-2 and IFN-g by T cells
Prazo: From baseline to up to 2 years
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Descriptive statistics will be used to describe the mean and spread of production of IL-2 and IFN-g.
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From baseline to up to 2 years
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Adverse events as assessed by Common Toxicity Criteria (CTC) version 2.0
Prazo: Up to 2 years
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Up to 2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Gajewski, Cancer and Leukemia Group B
Publicações e links úteis
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
Outros números de identificação do estudo
- NCI-2012-02958
- U10CA031946 (Concessão/Contrato do NIH dos EUA)
- CALGB-500104
- CDR0000299508
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