Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
Cytokines in the Treatment of Metastatic Renal Cell Carcinoma (MRCC): Intravenous Interleukin and Subcutaneous Interferon-α Versus Subcutaneous Interleukin and Interferon-α for Good Prognosis Patients [PERCY DUO]
RATIONALE: Biological therapies, such as interleukin-2 and interferon, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether interleukin-2 given by infusion is more effective than interleukin-2 given by injection when combined with interferon in treating metastatic kidney cancer.
PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with metastatic kidney cancer.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
Primary
- Compare the overall survival of patients with metastatic renal cell cancer treated with intravenous vs subcutaneous interleukin-2 in combination with interferon alfa.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare response rates (complete and partial) in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive induction therapy comprising interleukin-2 (IL-2) IV continuously over days 1-5, 15-19, 43-47, and 57-61 (weeks 1, 3, 7, and 9) and interferon alfa (IFN-α) subcutaneously (SC) three times weekly in weeks 1-3 and 7-9. Patients then undergo restaging. Patients achieving a complete response (CR), partial response (PR), or stable disease (SD) then receive maintenance therapy comprising IL-2 IV continuously over 5 days and IFN-α SC three times weekly in weeks 1, 5, 9, and 13.
- Arm II: Patients receive induction therapy comprising IL-2 SC twice daily on days 1-5, 8-12, 15-19, and 22-26 (weeks 1-4). Patients also receive IFN-α SC three times weekly in weeks 1-4 and 6-9. Patients then undergo restaging. Patients achieving a CR, PR, or SD then receive maintenance therapy comprising IL-2 SC as in induction therapy and IFN-α SC three times weekly in weeks 1-4 and 8-11.
Quality of life is assessed at baseline, at the end of induction therapy, and then at the end of maintenance therapy.
After completion of treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 3
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic renal cell adenocarcinoma
- More than one resectable metastatic site
- No unresectable lesions after local curative treatment (i.e., radiotherapy)
- In case of secondary lesions suspected on imaging (< 1 cm and/or sparse lesions), metastatic disease must be confirmed by biopsy OR disease progression documented by imaging performed over several weeks
- If patient has known prior metastatic lesions, progressive disease must have been confirmed within the past 3 months by noninvasive techniques
- Nephrectomized
- Measurable or evaluable disease
- No brain metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 90-100%
- Hematocrit ≥ 30%
- WBC ≥ 4,000/mm^3
- Platelet count ≥ 120,000/mm^3
- Bilirubin normal
- Creatinine ≤ 1.7 mg/dL
- FEV_1 ≥ 50%
No severe cardiac dysfunction (i.e., grade III/IV heart disease), including any of the following:
- Congestive heart failure
- Coronary artery disease
- Uncontrolled hypertension
- Severe arrhythmia
- No active infections requiring antibiotic treatment
- No severe neuropsychiatric condition
- No geographical, psychological, or familial conditions that would preclude study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF ≥ 50%
- No severe autoimmune disease
- No known chronic hepatitis
- No HIV positivity
- No hepatitis B surface antigen positivity
- No prior or concurrent other cancer, except basal cell skin cancer or carcinoma in situ of the cervix
- No severe pulmonary, hepatic, or renal condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior wide-field radiotherapy
- No prior allograft
- No prior cytokines or chemotherapy
- No concurrent corticosteroids
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Mascaramento: Nenhum (rótulo aberto)
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Sylvie Negrier, MD, Centre Léon Bérard
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária
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
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitais
- Neoplasias por local
- Doenças renais
- Doenças Urológicas
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias Renais
- Carcinoma de Células Renais
- Efeitos Fisiológicos das Drogas
- Agentes Anti-Infecciosos
- Antivirais
- Agentes anti-HIV
- Antirretrovirais
- Agentes Antineoplásicos
- Fatores imunológicos
- Interferons
- Interferon-alfa
- Aldesleucina
Outros números de identificação do estudo
- CDR0000468028
- LEONB-PERCY-DUO
- LEONB-ET99-057
- EU-20604
- ROCHE-LEONB-PERCY-DUO
- CHIRON-LEONB-PERCY-DUO
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