Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Reversal of alterations in the SN
研究概览
简要总结
This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage IB-II melanoma undergoing sentinel lymph node biopsy.
详细描述
PRIMARY OBJECTIVES:
I. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible.
II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes results in diminished regional tumor burden.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing sentinel lymph node biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 stage IB or II cutaneous melanoma
- •Primaries on the torso, upper and lower extremities and head and neck region
- •Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study
- •Bilirubin < 2.0 ng/dl
- •Creatinine < 3.0 ng/dl
- •Able to understand the consent competent to sign
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Prior wide excision with diameter of the excision > 3 cm
- •Primary melanoma arises from the eye or mucus membranes
- •Clinical evidence of regional, intransit ,or distant metastases
- •Second invasive melanoma
- •Prior surgical procedures that would alter the drainage patterns and would prevent us from identifying sentinel lymph nodes (SN)
- •Patients with primary or secondary immunodeficiencies
- •Pregnancy
- •Known allergy to sargramostim (GM-CSF)
- •History of cardiac disease, in particular, supraventricular tachycardia
结局指标
主要结局
Reversal of alterations in the SN
时间窗: Up to 30 days
A series of analysis of variance (ANOVA) models will be employed.
Proportion of subjects with positive SN in each group
时间窗: Up to 30 days
The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.
次要结局
- Overall survival (OS)(Up to 30 days)
- Disease free survival (DFS)(Up to 30 days)