A Phase II Study Of Autologous Tumor/DC Vaccine (DC Vaccine) Combined With Interleukin-2 (IL-2) And Interferon-α-2a (IFNα-2a) In Patients With Metastatic Renal Cell Carcinoma (RCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Clinical Response as Measured by RECIST
研究概览
简要总结
RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining vaccine therapy with interleukin-2 and interferon alfa may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with interleukin-2 and interferon alfa works in treating patients with metastatic renal cell carcinoma (kidney cancer).
详细描述
OBJECTIVES:
Primary
- Determine the clinical response rate in patients with metastatic renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with interleukin-2 and interferon-alfa.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine, within relevant immune pathways, the treatment-related, tumor-specific immune response in patients treated with this regimen.
- Correlate tumor-specific immune response with objective clinical response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic renal cell carcinoma with measurable disease.
- •Tumor tissue available and properly stored for lysate preparation.
- •Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects.
- •Karnofsky Performance Status ≥60%
- •Life expectancy ≥ twelve weeks
- •Adequate end organ function:
- •Hematological: ANC ≥ 1000cells/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8.5 g/dl
- •Liver: AST < 2 x ULN (upper limit of normal) unless due to metastases then < 5 x ULN, serum total bilirubin < 2 x ULN (except for patients with Gilbert's Syndrome)
- •Renal: serum creatinine < 2.0 x ULN.
- •Pulmonary: FEV1 > 2.0 liters or > 75% of predicted for height and age.
- •Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, or serious cardiac arrhythmias. Patients over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia.
- •CNS: No history of brain metastases.
- •Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.
- •Appropriate Contraception in both sexes
- •EXCLUSION CRITERIA:
- •Patients may have not have been treated previously with IL-2, IFNα or autologous vaccine.
- •Concomitant second malignancy except for non-melanoma skin cancer, and non- invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.
- •In patients with a prior history of invasive malignancy, less than five years in complete remission
- •Positive serology for HIV, hepatitis B or hepatitis C,
- •Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen.
- •Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 4 weeks must have passed since the last dose).
- •History of autoimmune disease.
排除标准
- 未提供
研究组 & 干预措施
Vaccine, Aldesleukin-2, Interferon-a
All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
干预措施: Aldesleukin, (Biological)
Vaccine, Aldesleukin-2, Interferon-a
All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
干预措施: autologous tumor cell vaccine (Biological)
Vaccine, Aldesleukin-2, Interferon-a
All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
干预措施: recombinant interferon alfa (Biological)
结局指标
主要结局
Clinical Response as Measured by RECIST
时间窗: monthly, then every 2-3 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Immunity as Measured by T-cell and Antibody Responses to the Tumor(monthly for 5 months)