NCT01896271已完成2 期
A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Metastatic Clear Cell Renal Cell Cancer (mRCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically when immediately followed by the non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the response rate and complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven metastatic clear cell RCC.
- •Radiographic evidence of metastatic disease. 2.1 Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist.
- •Patient must have ≥1 lesion of size >1.5cm.
- •Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed 28 days before the start of HD IL-2
- •Age ≥ 18 years.
- •Performance status ECOG 0,
- •Patient must be eligible for HD IL-2 treatment
- •Patient must be eligible for SABR to one or more extra cranial sites.
- •Adequate organ and marrow function as defined below:
- •leukocytes ≥ 3,000/mcL
- •absolute neutrophil count ≥ 1,500/mcL
- •platelets ≥ 50,000/mcl
- •total bilirubin ≤ 2mg/dL
- •AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •10.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Ability to understand and the willingness to sign a written informed consent
- •Adequate Renal function with Cr ≤ 1.6 mg/dL.
- •Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or Tc) stress test
- •Adequate pulmonary function on PFT (FEV1 >65%; DLCO>60%).
排除标准
- •Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- •History of HIV, Hepatitis B, Hepatitis C and HTLV serology
- •Subjects may not be receiving any other investigational or standard antineoplastic agents.
- •Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis
- •Subjects with life expectancy < 6 months.
- •History of allergic reactions to recombinant IL-2
- •Uncontrolled recurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,.
- •Psychiatric illness/social situations that would limit compliance with study requirements.
- •Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- •Systemic or topical steroid use or other immunosuppressive therapy within the past 28 days
- •Subjects required to take corticosteroids or other immunosuppressive therapy such as those with organ allograft
研究组 & 干预措施
treatment
Experimental
HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.
干预措施: IL-2 (Drug)
treatment
Experimental
HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.
干预措施: Stereotactic Ablative Body Radiation Therapy (Radiation)
结局指标
主要结局
Response Rate
时间窗: 6 months
Treatment response will be measured using the immune related Response Evaluation Criteria in Solid Tumors (RECIST) criteria (iRECIST) which are a minor modification of RECIST 1.1 for immunotherapy
次要结局
- Tumor-specific Immune Response(4 years)
- Progression Free Survival(4 years)
- Time to Progression(4 years)
- Median Response Duration(4 years)
- Overall Survival(4 years)
- Local Control Rate(4 years)
- Number of Participants With Adverse Events(4 years)
- Health-related Quality of Life (HRQoL).(4 years)
研究者
Raquibul Hannan
Principal Investigator
University of Texas Southwestern Medical Center
研究点 (1)
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