Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Survival as measured by Kaplan-Meier method at 5 years
研究概览
简要总结
RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may help them kill more cancer cells when they are put back in the body.
PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV kidney cancer.
详细描述
OBJECTIVES:
- Evaluate the ability of autologous lymphocyte therapy (ALT) given as adjuvant therapy following nephrectomy and/or complete surgical resection of any metastatic disease to delay or prevent metastatic recurrence in patients with high-risk renal cell carcinoma.
- Determine the incidence of tumor recurrence and the survival of these patients treated with this regimen.
- Determine the toxicity/morbidity of this regimen in these patients.
- Explore the relationship between clinical response and in vitro autologous lymphocyte characteristics, including lytic activity, cytokine production, response to cytokines, and phenotypic profile in these patients treated with this regimen.
- Assess patient immune status before, during, and after therapy.
OUTLINE: Patients are stratified according to postnephrectomy interval (less than 3 months vs more than 3 months), extent of lymph node involvement (N1 vs N2-N3), interleukin-1 concentration in initial autologous lymphocyte culture (less than 500 pg/mL vs greater than 500 pg/mL), and prenephrectomy treatment.
Mononuclear cells are collected by apheresis on day 1 and cultured with interleukin-2 and monoclonal antibody OKT3. After cellular production, the autologous lymphocytes are reinfused over at least 30 minutes. Treatment repeats monthly for 6 months and then every 3 months for 6 months in the absence of unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically documented and completely resected stage III or stage IV renal cell carcinoma, clinically staged within 2 months prior to initiation of therapy
- •No evidence of nephrotic syndrome
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count 50,000/mm3 to 500,000/mm^3
- •Hemoglobin at least 10 g/dL
- •No hematologic abnormalities
- •PT no greater than 1.5 times control
- •PTT less than 1.5 times control
- •Hepatitis B surface antigen negative
- •Creatinine no greater than 4.0 mg/dL
- •Calcium no greater than 12 mg/dL
- •No symptomatic hypercalcemia
- •Cardiovascular:
- •No uncontrolled or severe cardiac disease, e.g.:
- •No myocardial infarction within 6 months
- •No congestive heart failure
- •HIV negative
- •No significant organ dysfunction
- •No other serious medical illness that would limit life expectancy
- •No significant CNS disease including uncontrolled or untreated psychiatric or seizure disorders
- •No uncontrolled bacterial, viral, or fungal infection
- •No active peptic or duodenal ulcer
- •Adequate peripheral venous access required
- •No prior malignancy within past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix
- •Not pregnant
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •No other concurrent postnephrectomy adjuvant therapy
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No concurrent chemotherapy
- •Endocrine therapy:
- •More than 1 week since prior corticosteroids (except as inhalation therapy for respiratory ailments or replacement for adrenal insufficiency)
- •No concurrent therapy with the following:
- •Estrogens (except as postmenopausal replacement therapy)
- •Androgens
- •Progestins
- •Antiestrogens
- •Antiandrogens
- •LHRH analogues or antagonists
- •Other hormones
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Survival as measured by Kaplan-Meier method at 5 years
Onset of recurrence as measured by Kaplan-Meier method at 5 years
Safety as measured by NCI Common Toxicity Criteria at completion of study
次要结局
未报告次要终点