Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
研究概览
简要总结
Goal: To characterize the cellular events that occur in vivo after vaccination with an emulsion of GMCSF-in-adjuvant.
Design: Open-label, single dose study in two stages.
详细描述
Regimen: Each injection will be administered to patients with clinical stage I or II melanoma, who have had complete excision of a primary melanoma, but prior to wide excision with or without sentinel node biopsy as definitive surgical therapy.
In Stage 1: Patients will be injected with a 1 ml emulsion containing GM-CSF in saline plus Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In Stage 2: Patients will be randomized to receive an injection of one of the following in skin adjacent to the melanoma biopsy scar:
- 1 ml saline
- GM-CSF in 1 ml saline
- an emulsion of Montanide ISA-51 adjuvant and saline
- an emulsion of GM-CSF in saline plus ml Montanide ISA-51 adjuvant. All vaccines will be administered intradermally. After the injection, each patient will undergo wide excision of the melanoma site, with or without sentinel node biopsy, as clinically indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed, by histologic and clinical examination, with resected AJCC stage I or II melanoma.
- •Patients who have any evidence of metastasis will not be eligible.
- •All patients must have:
- •Karnofsky performance of 80% or higher
- •ECOG performance status of 0 or 1
- •Ability and willingness to give informed consent
- •Laboratory parameters as follows:
- •ANC: 90% of lower limit of normal (LLN) to 120% of upper limit of normal (ULN)
- •Platelets: 100-500 x 103/uL
- •Hgb: 90% LLN to 120% ULN
- •AST, ALT, Bilirubin, and Alk phos within normal limits,
- •LDH up to 1.2 x ULN
- •Creatinine up to 1.5 x ULN
- •Age 18-85 years at the time of study entry.
排除标准
- •Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 12 weeks.
- •Patients with known or suspected allergies to any component of the vaccine.
- •Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
- •Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents),
- •Allergy desensitization injections,
- •Corticosteroids, administered parenterally or orally. Topical corticosteroids are acceptable.
- •Any growth factors, Interleukin-2 or other interleukins.
- •Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the injection.
- •Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
- •Patients classified according to the New York Heart Association classification as having Class III or IV heart disease.
- •Patients with serious symptomatic active pulmonary disease, with pleural effusions, or with a history of pulmonary edema.
- •Patients who have systemic autoimmune disease with visceral involvement.
- •Patients with clinically apparent skin infection or other clinically evident inflammation involving the skin adjacent to the melanoma biopsy scar.
研究组 & 干预措施
Saline
first of 4 arms: injection: 1 ml saline
干预措施: Saline (Drug)
GM-CSF
Second of 4 arms: injection: specified dose of GM-CSF in 1 ml saline
干预措施: GM-CSF-in-adjuvant (Drug)
0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline
Third of 4 arms: injection: 0.5 ml Montanide ISA-51 adjuvant and 0.5 ml saline
干预措施: Montanide ISA-51 (Drug)
GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant
Fourth of 4 arms: injection: specified dose of GM-CSF in 0.5 ml slaine plus 0.5 ml Montanide ISA-51 adjuvant
干预措施: GM-CSF and Montanide ISA-51 (Biological)
结局指标
主要结局
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
Proportion of the sentinel node occupied by dendritic cells (total and mature)
次要结局
- Time to maximal dendritic cell infiltration into the dermis