NCT00104897已完成2 期
A Phase II Trial to Assess the Activity of 17-allylamino, 17-demethoxygeldanamycin (17-AAG) in Patients With Metastatic (M1, M1b & M1c) Malignant Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Disease stabilization at 6 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic malignant melanoma.
- Determine the progression-free rate in patients treated with this drug.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the duration of response in patients treated with this drug.
- Determine the survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed malignant melanoma
- •Metastatic (M1a, M1b, or M1c) disease
- •Measurable disease by clinical exam, x-ray, CT scan, or MRI
- •Must have documented disease progression at 2 time points separated by ≥ 6 months
- •Pre-existing visceral lesions or the appearance of new visceral lesions allowed
- •New skin disease amenable to surgery not allowed
- •No primary brain tumors or brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Bilirubin normal
- •ALT and AST ≤ 1.5 times upper limit of normal
- •No chronic liver disease
- •No known hepatitis B or C positivity
- •Creatinine < 130 mmol/L OR
- •Creatinine clearance > 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No myocardial infarction within the past 6 months
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No transient ischemic attack
- •No stroke or peripheral vascular disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 4 weeks before, during, and for 6 months after study participation
- •No ongoing or active infection
- •No diabetes mellitus with evidence of severe peripheral vascular disease or ulcers
- •No history of allergy to eggs
- •No known HIV positivity
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No other malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Endocrine therapy
- •More than 4 weeks since prior endocrine therapy
- •Concurrent steroids allowed provided they are given at the lowest possible maintenance dose
- •Radiotherapy
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease stabilization at 6 months
次要结局
- Toxicity profile as measured by NCI CTCAE version 3
- Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1
- Response duration
- Survival
- B-RAF and RAS mutation status at baseline
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Kidney CancerKidney CancerNCT00093405Memorial Sloan Kettering Cancer Center
已完成
2 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic MastocytosisNonneoplastic ConditionChronic Myeloproliferative DisordersPrecancerous ConditionLymphomaLeukemiaNCT00132015National Institutes of Health Clinical Center (CC)37
已完成
1 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib MesylateLeukemiaNCT00100997Jonsson Comprehensive Cancer Center
已完成
1 期
17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in Treating Patients With an Advanced Solid Tumor or LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol SpecificLymphomaNCT00088868National Institutes of Health Clinical Center (CC)40
已完成
1 期
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By SurgeryUnspecified Adult Solid Tumor, Protocol SpecificLymphomaNCT00004075Mayo Clinic