- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00030342
Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
A Phase I/II Study Of Interleukin-12-Primed Activated T Cells In Combination With 5FU, GM-CSF And Interferon Alfa-2b In Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of biological therapy combined with chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.
Visão geral do estudo
Status
Condições
Descrição detalhada
OBJECTIVES:
- Determine the safety of a repeat course of interleukin-12-primed activated T cells (12ATC) in combination with fluorouracil, sargramostim (GM-CSF), and interferon alfa-2b in patients with metastatic renal cell or colorectal carcinoma.
- Determine the clinical responses of patients treated with this regimen.
- Determine the efficacy of 12ATC in these patients.
- Determine whether there are changes in immunologic parameters related to 12ATC as measured by lymphocyte phenotype and cytokine secretion in these patients.
- Determine the correlation between clinical responses in patients treated with this regimen and in vitro immune functions of lymphocytes.
OUTLINE: Patients are stratified according to disease type (renal cell carcinoma vs colorectal carcinoma).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-5 and then undergo collection of autologous peripheral blood mononuclear cells (PBMC) on days 6 and 7 of week 1. The PBMC are treated ex vivo to form interleukin-12-primed activated T cells (12ATC).
Patients receive fluorouracil IV over 24 hours on day 6 of week 2 and interferon alfa-2b SC and GM-CSF SC 3 times weekly on weeks 3-5. Patients receive 12ATC IV over 15-30 minutes twice weekly and interferon alfa-2b SC (at least 24 hours after 12ATC infusion) once weekly on weeks 6-8. Patients with complete or partial response or stable disease at 3 weeks after the last 12ATC infusion may receive an additional 8-week course as above.
Patients are followed every 2-3 months for 1 year and then every 6 months for 2 years or at any time when the physical examination or symptoms are suspicious for tumor progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 2-3 years.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical 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 metastatic renal cell carcinoma or colorectal carcinoma, meeting 1 of the following criteria:
- Obtained no benefit from prior standard or salvage therapy
- Ineligible for standard therapy because of concurrent illness
- Declined standard therapy
At least 1 site of measurable disease that can be measured in at least 1 dimension
- At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan
- No untreated or unstable, treated brain metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 4,000/mm^3
- Granulocyte count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
- No coagulation disorders
Hepatic:
- Bilirubin no greater than 2.5 mg/dL*
- ALT/AST less than 3 times upper limit of normal*
- PT no greater than 1.5 times control (unless therapeutically anticoagulated)
- PTT less than 1.5 times control (unless therapeutically anticoagulated) NOTE: *Patients whose cancer has led to values that do not fall within the above ranges may be eligible at the discretion of the investigators
Renal:
- Creatinine no greater than 2.0 mg/dL* NOTE: *Patients whose cancer has led to values that do not fall within the above range may be eligible at the discretion of the investigators
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No thrombophlebitis
Pulmonary:
- FEV_1 and FVC at least 65% predicted
- No uncontrolled pulmonary embolism
Other:
- No other malignancy within the past 5 years except resected basal cell skin cancer or carcinoma in situ of the cervix
- No prior allergic reactions attributed to compounds of similar chemical or biologic composition to interleukin-12-primed activated T cells or other study agents
- No active autoimmune disease
- No uncontrolled thyroid abnormalities
- No ongoing or active infection
- No other uncontrolled concurrent illness
- No psychiatric illness or social situations that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 2 years after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 4 weeks since prior immunotherapy
Chemotherapy:
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
- At least 4 weeks since prior steroid therapy or steroid-containing compounds
- At least 2 weeks since prior topical or inhaled steroids
Radiotherapy:
- More than 4 weeks since prior radiotherapy and recovered
Surgery:
- More than 4 weeks since prior major surgery
Other:
- No other concurrent investigational agents
- No other concurrent commercial anticancer agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Sobrevida medida pelo método Kaplan-Meier em 5 anos
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Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years
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Safety as measured by NCI common toxicity table at study completion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: John P. Hanson, MD, St. Luke's Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
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
- Doenças do aparelho digestivo
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitais
- Neoplasias por local
- Doenças renais
- Doenças Urológicas
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Doenças Intestinais
- Neoplasias Intestinais
- Doenças retais
- Neoplasias Renais
- Carcinoma de Células Renais
- Neoplasias Colorretais
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Interferons
- Interferon-alfa
- Fluorouracil
- Sargramostim
Outros números de identificação do estudo
- STLMC-IMM-0104
- CDR0000069153 (Identificador de registro: PDQ (Physician Data Query))
- STLMC-L-01108
- NCI-V01-1686
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