A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in CD8+ T cell frequency
研究概览
简要总结
This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
详细描述
PRIMARY OBJECTIVES:
I. To assess the toxicity of booster vaccination with the gp100 (gp100:209-217(210M) peptide vaccine) and human papilloma virus (HPV) peptides in Montanide ISA 51 or Montanide ISA 51 VG administered >= 12 months after the last immunization.
II. To measure the T-cell response to the modified gp100: 209-217 (210M) peptide and the unmodified native gp100 peptide following booster vaccination >= 12 months after the last immunization.
III. To measure the T-cell response to the control human leukocyte antigen (HLA)-A2 restricted clusters of differentiation (CD)8 epitope of papilloma virus HPV16E7:12-20 following booster vaccination >= 12 months after the last immunization.
IV. To perform detailed studies of the memory T cells persisting >= 12 months after immunization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have completed treatment on protocol 99-9 [T98-0081] "A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide Vaccine in HLA-A2.1+ Patients with a > 1mm Melanoma on Initial Biopsy;" patients are not required to have received every planned vaccine as long as the reason for stopping was not disease progression or dose limiting toxicity
- •Patients must be >= 12 months from their last vaccination with gp100 and be free of melanoma; patients who have remained continuously free of disease and patients who have had a recurrence that has been completely resected (stage IV no evidence of disease [NED]) are eligible
- •Patients must have a good performance status (Karnofsky performance status [PS] 80-100)
- •White blood cells (WBC) >= 3500/mm^3
- •Platelets (plt) >= 100,000/mm^3
- •Hemoglobin >= 9 gm/100 ml
- •Serum creatinine =< 2 mg/dl
- •Total bilirubin =< 2.0 mg/dl
- •Patients must have recovered from any effects of major surgery and be free of significant systemic infection
- •Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment; men must avoid fathering a child while on treatment
- •Patients must give written informed consent prior to initiation of therapy
- •Patients with a history of psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy
排除标准
- •Patients must not have clinically detectable melanoma
- •Patients who require or are likely to require systemic corticosteroids for intercurrent illness are ineligible
- •Patients with any significant medical disease other than the melanoma, which in the opinion of the investigator would significantly increase the risk of immunotherapy, are ineligible
- •Patients should be free of any other cancers or deemed at low risk for their recurrence
结局指标
主要结局
Change in CD8+ T cell frequency
时间窗: Up to 11 years
Differences in immune parameters will be graphically depicted by means of density plots, frequency histograms, box and whisker-plots, dot-plots, trellis graphics (where appropriate) and other plots and graphs. Analyses of continuous variables will be performed first on the original frequency data. Goodness of fit statistics will be employed to determine whether assumptions underlying test statistics (e.g., normality) are satisfied. If assumptions for the test procedures are violated, then rank-transformed or arcsin-transformed data will be used. Probability tests will be two-sided.
Percentage of positive CD8+ T cells
时间窗: Up to 11 years
Characterized using three different in vitro assays. Fresh and cryopreserved peripheral blood mononuclear cells (PBMC) will be analyzed for gp100 peptide-specific CD8+ T cells using a fluorescinated, modified gp100, peptide-specific, A2-restricted tetramer binding assay and the interferon (IFN) gamma specific enzyme-linked immunosorbent spot (ELISPOT) and cytokine flow cytometry (CFC) assays.
次要结局
未报告次要终点