Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studied.
详细描述
Some of the drugs in this study have been used with DTIC (Dacarbazine) in the past to control Melanoma that has spread to other parts of the body. However, in most of those cases, the duration of these results are limited and ineffective to control or prevent spread of the disease into the brain, the membranes that cover the brain, the spinal cord, and the nerve roots. In this study, temozolomide is being used instead of DTIC. Temodar has been proven to be one of the most effective therapeutic agents to control malignancies in the brain. Thalidomide is designed to decrease the formation of new blood vessels that feed tumors.
The treatment plan for this study is divided in two parts. The first part of this study (induction therapy) is done to try to get your disease under control. The second part of this study (maintenance therapy) is to maintain or improve the results of the first part of the treatment plan.
Induction Therapy:
Induction therapy includes three 5-day courses of treatment with thalidomide, temozolomide, vinblastine, cisplatin, interleukin-2, and interferon-alpha. The courses are repeated in cycles of three to four weeks depending on recovery from side effects from the previous course of treatment.
All of the drugs that are given through a vein will be given through a catheter (plastic tube) inserted in a vein in one of your arms or into the vein that runs underneath the collar bone and threaded into the central vein in the upper part of the chest.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
- •They should have recurrent melanoma with measureable or evaluable sites of disease in order to assess the response to treatment by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- •Patients between 18 years of age and 65 years of age with an expected survival greater than 8 weeks and a Karnofsky performance status of 50% or better or an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 will be eligible.
- •They should have normal blood counts with a white blood count (WBC) count of more than or equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3 and a platelet count of more than 100,000/mm^3 and have no impairment of renal function (serum creatinine of less than 1.6 mg/dl), hepatic function (serum bilirubin level of < 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
- •They should have no significant intercurrent illness such as an active infection, uncontrolled psychiatric illness, hypercalcemia (calcium > 11 mg), or active GI bleeding.
- •They should not have been exposed to any previous chemotherapy or isolation perfusion for malignant melanoma and have had no previous exposure to interleukin-
- •Prior adjuvant interferon is permitted. Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
排除标准
- •Patients with brain and/or bone metastases only.
- •Patients with symptomatic central nervous system involvement by melanoma either as brain metastasis by MRI or spinal cord compression. Patients with brain metastases are not eligible unless their disease can be resected, it is asymptomatic, not associated with cerebral edema, or they are clinically stable after radiation and off corticosteroid therapy for 4 weeks. No major surgery or RT within 21 days before starting of treatment.
- •Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF <55%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with an electrocardiogram (EKG) disclosing an absolute QT interval >460 msec in the presence of serum potassium >/=4.0 mEq/L and magnesium >/= 1.8 mg/dL. Patients with heart rate less than
- •Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of Left Ventricular Ejection Fraction (FE VI) to <75% of predicted normal values.
- •Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
- •Patients who are unable to stay in Houston to receive therapy (first cycle) and be able to return for follow-up visits as required by this study.
- •Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 5 years and uncertainty about the histological nature of the metastatic lesions.
- •Patients with history of deep vein thrombi (DVT) or pulmonary embolism (PE) are excluded.
研究组 & 干预措施
Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
干预措施: Temozolomide (Drug)
Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
干预措施: Velban (Drug)
Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
干预措施: Cisplatin (Drug)
Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
干预措施: Interleukin-2 (Drug)
Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
干预措施: Intron-A (Drug)
Biochemotherapy with Temozolomide
Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
干预措施: Thalidomide (Drug)
结局指标
主要结局
Time to Progression (TTP)
时间窗: Following two 21 day cycles until disease progression
TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
次要结局
- Number of Participants With Response(Following each 21 day cycles)