Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety of the Vaccine
研究概览
简要总结
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, and sargramostim (GM-CSF) emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer.
OUTLINE: This is an open-label study.
Patients receive vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, sargramostim (GM-CSF), and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine. Patients then receive additional vaccine as above only to the primary vaccination site on days 29, 36, and 43.
After completion of study treatment, patients are followed at 1 week, 1 month, every 3 months for 9 months, every 6 months for 1 year, and then annually thereafter.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial or primary peritoneal cancer
- •Completed primary therapy (surgery and chemotherapy for newly diagnosed disease) within the past 12 months and meets 1 of the following criteria:
- •Clinical or radiographic evidence of disease
- •Serologic evidence of disease
- •Initial diagnosis of stage III or IV disease AND completed anticancer therapy within the past 12 months
- •At least 2 intact axillary and/or inguinal lymph node basins
- •Prior lymph node biopsy allowed provided lymphoscintigraphy demonstrates intact drainage to a node in that basin
- •HLA-A1-, -A2-, or -A3-positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Hemoglobin > 8.0 g/dL OR
- •Hematocrit > 25%
- •Platelet count ≥ 80,000/mm^3
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Hepatitis C negative
- •Not specified
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •Immunologic
- •HIV negative
- •No active infection requiring antibiotics
- •No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- •No prior autoimmune disorder with visceral involvement
- •No known or suspected allergy to any component of the study vaccine
- •The following immunologic conditions are allowed:
- •Laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer) that is asymptomatic
- •Clinical evidence of vitiligo or other forms of depigmenting illness
- •Mild arthritis requiring non-steroidal anti-inflammatory drugs
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Weight ≥ 110 lbs
- •No uncontrolled diabetes, defined as hemoglobin A1C ≥ 7%
- •No active hyperthyroidism
- •No current or recent (within the past year) addiction to alcohol or drugs
- •No medical contraindication or other potential medical problem that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 2 weeks since prior and no concurrent allergy desensitization injections
- •More than 2 weeks since prior and no concurrent growth factors (e.g., epoetin alfa or pegfilgrastim)
- •More than 1 month since prior and no other concurrent immunotherapy
- •More than 2 weeks since prior and no other concurrent potential immunomodulating agents, including any of the following:
- •Interferon
- •Tumor necrosis factor
- 另有 17 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety of the Vaccine
时间窗: Days 1,8,15,22,29,36,43,50
Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
时间窗: Day 22
次要结局
- Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay(Days 1,8,15,22,29,36,43,50 and Month 3)
研究者
Amir Jazaeri
Principal Investigator
University of Virginia