DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating

Обзор

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.

Подробное описание

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.

Primary

1\. Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).

Secondary

1. Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen. 2. Determine safety of multiple administrations of this regimens in these patients.

Вмешательства

• Биопрепарат DC-CIK
  Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
• Биопрепарат IL-2/IFN-α
  Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.

Первичные конечные точки

• Progression-free time [Срок оценки: 3 months]
• Overall-survival time [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Objective tumor response [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Histologically proven renal cell carcinoma
• Age: > 18
• WHO- ECOG Performance Status 0-1
• At least one measurable tumor lesions according to the RECIST criteria.
• Life expectancy more than 3 months
• Written informed consent

Критерии исключения

• Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
• Patients with metastatic disease in the central nervous system (CNS).
• Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
• Patients with acute or chronic infection including HIV.
• Patients who are pregnant or nursing.
• Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
• Patients who receive corticosteroids or other immunosuppressive agents.
• Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT02487550 · CIKRC001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗