- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00019487
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule.
- Determine the survival of infused cells with antitumor activity in these patients.
OUTLINE: This is a salvage regimen.
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated.
Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.
Tipo de estudo
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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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 proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule
- Measurable or evaluable metastatic disease
- Must be HLA-A201 positive by standard HLA typing
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Greater than 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8.0 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT/AST less than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.6 mg/dL
Cardiovascular:
For patients randomized to receive interleukin-2:
- No major medical illnesses of the cardiovascular system
Pulmonary:
For patients randomized to receive interleukin-2:
- No major medical illnesses of the pulmonary system
Other:
- HIV negative
- Hepatitis B antigen negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
For patients randomized to receive interleukin-2:
- No active systemic infection
- No other major medical illnesses of immune system
- No coagulation disorders
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- No concurrent steroid therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No concurrent active treatment of brain metastases
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
Colaboradores e Investigadores
Patrocinador
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
- Agentes Anti-Infecciosos
- Antivirais
- Agentes anti-HIV
- Antirretrovirais
- Agentes Antineoplásicos
- Fatores imunológicos
- Adjuvantes Imunológicos
- Aldesleucina
- Adjuvante de Freund
Outros números de identificação do estudo
- CDR0000066287
- NCI-98-C-0095
- NCI-T98-0012
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 .
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