NCT01119508已完成2 期
Phase II Study of Ipilimumab Plus Temozolomide in Patients With Metastatic Melanoma
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
- 64
- 试验地点
- 1
- 主要终点
- 6-Month Progression-Free Survival (PFS) Rate
研究概览
简要总结
The goal of this clinical research study is to learn if combining ipilimumab and temozolomide can help to control metastatic melanoma. The safety of this drug combination will be studied. Researchers would also like to study how this therapy affects the levels of certain chemicals in the blood that are related to your immune system.
详细描述
The ability to control melanoma depends on how well your immune system recognizes and then attacks cancer cells. Researchers want to use ipilimumab to try to trigger your immune system response, while temozolomide is designed to damage the cancer cells themselves.
Study Drugs:
Ipilimumab is designed to block the activity of cells that lower the immune system's ability to fight cancer. Blocking these cells may help the body's immune system fight the cancer cells better.
Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). If they cannot make DNA, then they cannot divide into new cancer cells.
Study Drug Administration:
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 75 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/inoperable metastatic melanoma of skin or mucosal origin are eligible, provided they fulfill the following conditions:
- •They are 18 years old to 75 years old with measurable (at least 1 cm) metastatic disease.
- •They have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Must be at least 21 days since surgery, radiation therapy and 6 weeks after immunotherapy with regimens including vaccine, interferon, IL-2 etc. and fully recovered from adverse effects of these therapies.
- •Must agree not use vaccines for the treatment of cancer or prevention of disease unless indicated as a component of the protocol regimen (including those for common medical conditions) for up to one month pre and post dosing with ipilimumab.
- •Required values for initial laboratory tests: white blood cell count (WBC): 2000/uL or greater, absolute neutrophil count (ANC): 1000/uL or greater, Platelets: 100 x 103/uL or greater, Hemoglobin: 9 g/dL or greater, Creatinine: </=1.5 mg/dL, AST and ALT: </= 2.5 x upper limit of normal (ULN) for subjects without liver metastasis or, </= 5 X upper limit of normal (UNL) for liver metastases, Bilirubin: </= 1.5 mg/dL, LDH </= 2 X upper limit of normal (UNL).
- •They have no significant intercurrent illness such as a serious infection which requires intravenous antibiotics. No active or chronic infection with HIV, Hepatitis B, or Hepatitis C. No significant psychiatric illness, which includes any life threatening psychiatric illness that has not been adequately controlled despite intervention (with or without medication) despite 6 months of therapy. They should have no GI tract metastasis or bleeding, no autoimmune disease.
- •They have not been previously exposed to any cytotoxic drugs, targeted therapies or anti CTLA 4 drugs for metastatic melanoma. Patients that received interferon for melanoma in the adjuvant setting are eligible. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and any toxicity has returned to baseline.
- •Patients with brain metastases who have been treated with craniotomy and resection or stereotactic radiosurgery of all symptomatic brain metastases are eligible provided they are 4 weeks from the procedures, MRI/CT of the brain performed within 3 weeks from registration fails to show new metastases and they are off of steroids for at least 2 weeks. Patients previously treated with whole brain radiotherapy are eligible if they are without tumor progression in the brain at least 8 weeks from completion of radiotherapy and are asymptomatic. They should be off steroid therapy for at least 2 weeks.
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized. In general, the decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
- •(Continued 10) WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. Post-menopause is defined as: 1) Amenorrhea 12 consecutive months without another cause, or 2) For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level 35 milli-International unit (mIU)/mL.
- •(Continued 11) Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.
- •Men should use condoms while participating in this study.
- •must agree not to use vaccines for the treatment of cancer or prevention of disease unless indicated as a component of the protocol regimen (including those for common medical conditions) for up to one month pre and post dosing of ipilimumab.
排除标准
- •Patients with Uveal melanoma. Patients with skin or mucosal melanoma who are younger than 18 years or more than 75 years of age and those with an ECOG performance status of 2, 3 or 4, or patients without measurable metastases.
- •Patients with prior cytotoxic, targeted therapy or anti-CTLA 4 drugs for metastatic disease.
- •Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function or serious cardiac arrhythmias requiring therapy. Borderline cases must be discussed with the PI.
- •Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD). Pulmonary function test with the results forced expiratory volume at one second (FEV1) <65% or forced vital capacity (FVC) <65% of predicted. Borderline cases must be discussed with the PI.
- •Patients on corticosteroids or any other type of immunosuppressive agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide) at time of enrollment only.
- •Patients with history of second malignancies such as basal cell carcinoma, squamous cell carcinoma and carcinoma in situ of cervix are eligible for therapy. Patients with history of other types of cancers, are eligible provided that they have been free of recurrence from second malignancy for at least 3 years. Each case must be discussed with the PI prior to registration.
- •Patients with symptomatic uncontrolled brain metastasis that is associated with significant brain edema requiring steroid therapy. Patients will be evaluated by the principal investigator or his designee. Patients with spinal cord metastasis or meningeal carcinomatosis.
- •WOCBP who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy. Acceptable contraceptive methods are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy).
研究组 & 干预措施
Ipilimumab + Temozolomide
Experimental
Induction: Ipilimumab 10 mg/kg IV over 90 minutes Day 1 + Temozolomide 200 mg/m2 PO on Days 1 - 4, every 3 weeks for 4 courses over 3 months.
干预措施: Ipilimumab (Drug)
Ipilimumab + Temozolomide
Experimental
Induction: Ipilimumab 10 mg/kg IV over 90 minutes Day 1 + Temozolomide 200 mg/m2 PO on Days 1 - 4, every 3 weeks for 4 courses over 3 months.
干预措施: Temozolomide (Drug)
结局指标
主要结局
6-Month Progression-Free Survival (PFS) Rate
时间窗: 6 Months
6-month progression free survival rate is defined as the number of participants without progression per RECIST 1.0 6 months after starting study treatment.
次要结局
未报告次要终点
研究者
研究点 (1)
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