NCT01897116已完成1 期
A Phase I Trial of Vemurafenib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of BRAF V600E+ metastatic melanoma.
详细描述
This study is testing vemurafenib and hydroxychloroquine (HCQ) in the treatment of metastatic BRAF V600E+ melanoma. Patients will be getting a known active treatment for their disease in combination with HCQ which may help overcome resistance so that responses to vemurafenib are more durable.
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
- Single (Participant)
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
- •Patients must be at least 18 years of age.
- •Patients must have histologically confirmed diagnosis of Stege IV metastic melanoma positive for BRAF V600E mutation by either the COBAS test or other CLIA approved assay.
- •Patients must have a ECOG performance status of 0 or
- •Patients must have the following hematologic, renal and liver function: absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, hemoglobin >9g/dL, creatinine ≤ 2 times the upper limits of normal (ULN), albumin > 2g/dL, total bilirubin ≤ 1.5 mg/dl, ALT and AST ≤ 3 times above the upper limits of the institutional norm.
- •Patients must be able to provide written informed consent.
- •Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either sugically sterile or have been postmenopausal for ≥ 1 year.
- •Fertile men and women must an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistenly and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence (e.g. calendar, ovulation, sympothermal, postovulation methods) with withdrawal are not acceptable methods of contraception.)
- •Patients with treated brain metastases that have been stable for 1 month are eligible; patients must be off steroids for 1 week prior to starting study treatment.
- •Any number and type of prior anticancer therapies except BRAF or MEK inhibitors.
- •Patients must have discontinued active immunotherapy (IL-2, interferon, CTLA-4, etc.) or chemotherapy at least 4 weeks prior to entering the study and oral targeted therapy at least 2 weeks prior to entering the study and have recovered from adverse events due to those agents. Patients must not receive any other investigational anticancer therapy during the period on study or the four weeks prior to entry, with the exception of vaccines.
排除标准
- •Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
- •Patients who are pregnant and breast-feeding.
- •Patients receiving concurrent therapy for their tumor (i.e.chemotherapeutics or investigational agents).
- •Patients with leptomeningeal disease.
- •Patients with a concurrent or prior malignancy within the last 2 years, unless they are patients with curatively treated carcinoma-in-situ, or basal cell carcinoma or squamous cell carcinoma of the skin. Patients with treated prostate cancer or breast cancer for which no concurrent therapy is indicated are eligible for this study. Patients who have been free of disease (any prior malignancy) for ≥ five years are eligible for this study.
- •Due to risk of disease exacerbation patients with porphyria are not eligible.
- •Due to risk of disease exacerbation patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
- •Patients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (EIADs) (i.e. phenytoin, carbamazepine, Phenobarbital, primidone, or oxcarbazepine) are ineligible.
- •Patients with previously documented macular degeneration or diabetic retinopathy are ineligible.
- •Patients with prior exposure to BRAF or MEK inhibitors are not eligible.
- •Because patients witn immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded from the study. For patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with HCQ and VEM is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retrovital therapy in the future.
- •History of congenital long QT syndrome or a corrected QTc interval ≥ 450 msec at baseline.
结局指标
主要结局
Number of Adverse Events
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by SurgeryBRAF NP_004324.2:p.V600XKRAS wt AlleleMetastatic Malignant Solid NeoplasmStage IV Colorectal Cancer AJCC v7Stage IVA Colorectal Cancer AJCC v7Stage IVB Colorectal Cancer AJCC v7Unresectable Solid NeoplasmNCT01787500M.D. Anderson Cancer Center47
已完成
1 期
Study of Vemurafenib, Carboplatin, and PaclitaxelAdvanced CancersNCT01636622M.D. Anderson Cancer Center21
已完成
1 期
Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF MutationsAdvanced Malignant NeoplasmBRAF Gene MutationMetastatic Malignant NeoplasmRecurrent Malignant NeoplasmRefractory Malignant NeoplasmNCT01531361M.D. Anderson Cancer Center46
撤回
1 期
Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain MetastasesRecurrent MelanomaStage IV MelanomaTumors Metastatic to BrainNCT02145910Sidney Kimmel Cancer Center at Thomas Jefferson University
进行中（未招募）
1 期
Evaluate the safety and the efficacy of Vemurafenib/PEG-interferon in melanoma patientsEvaluate the safety and the efficacy of Vemurafenib/PEG-interferon combination and the IFNAR1 upregulation lead by this treatment in advanced melanoma patients harboring the V600BRAF mutationMedDRA version: 14.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864EUCTR2013-003730-33-ITFondazione Melanoma ONLUS48