NCT00673361终止2 期
Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have histologically or cytologically confirmed melanoma that is locally advanced or metastatic. Cutaneous, mucosal, ocular, and unknown primary melanoma are all eligible.
- •Must have measurable disease, defined by RECIST as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or >10mm with spiral CT scan.
- •May have received prior radiation therapy to one or more non-index lesions (prior radiation to an index lesion is allowable only if progression of the irradiated lesion is demonstrated, with progression defined as an increase of 20% or more in the largest diameter) and/or one prior vaccine therapy for metastatic disease. Prior adjuvant therapy with IFN alpha-2b, vaccine, and/or granulocyte-macrophage colony-stimulating factor (GM-CSF) is permitted. At least 4 weks must have elapsed since the completion of any prior therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes >3,000/uL (microliters)
- •absolute neutrophil count >1,500/uL
- •platelets >100,000/uL
- •total bilirubin <2.0mg/dL
- •AST (Aspartate transaminase)(SGOT)/ALT (Alanine transaminase)(SGPT) <2.5 X institutional upper limit of normal
- •creatinine <1.8mg/dL
- •If >50 years of age with one or more cardiac risk factors, must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation.
- •Must be at least 2 weeks out from major surgery and be free of any active infection requiring antibiotics.
- •Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Women must demonstrate a negative pregnancy test prior to initiation of protocol therapy.
- •Ability to understand and the willingness to sign a written informed consent form.
排除标准
- •Prior chemotherapy, cytokine therapy (including IL-2 or IFN alpha), or antibody therapy for metastatic disease. Prior vaccine therapy is permitted.
- •May not be currently receiving any other antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccine, or investigational agents.
- •History of brain metastases.
- •Autoimmune disorders that could result in life-threatening complications in the setting of IFN alpha and IL-2 treatment.
- •History of sensitivity to E. coli-derived products.
- •Concurrent use of corticosteroids or any medical condition likely to require the use of systemic corticosteroids.
- •A seizure disorder currently requiring anti-epileptic medication.
- •Uncontrolled intercurrent illness including, but not limited to, hypertension, active infection requiring antibiotic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Evidence of bleeding diathesis.
- •Currently on therapeutic anticoagulation. Prophylactic anticoagulation (such as low-dose warfarin) of venous or arterial access devices is allowed provided the PT, PTT (Partial Thromboplastin Time), and international normalized ratio (INR) are normal.
研究组 & 干预措施
"Chemo-Switch" Regimen
Experimental
干预措施: Concurrent decrescendo biochemotherapy regimen (Drug)
"Chemo-Switch" Regimen
Experimental
干预措施: Low-dose Temozolomide plus Sorafenib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 3 weeks, 6 weeks, 16 weeks, & 24 weeks
Terminated study before accrual goal, no data analysis
次要结局
- Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria(post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years)
研究者
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