NCT00118313已完成1 期
Evaluation of Different Adjuvants for the Transdermal Administration of a Peptide-Based Vaccine in Participants With High-Risk Melanoma
Craig L Slingluff, Jr1 个研究点 分布在 1 个国家开始时间: 2004年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Safety if less than 33% of patients experience a dose-limiting at day 22
研究概览
简要总结
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the safety of adjuvant transdermal vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) in combination with Montanide ISA-51 or dimethyl sulfoxide with or without imiquimod in patients who have undergone surgical resection for stage II-IV melanoma.
- Determine, preliminarily, the immunogenicity of these regimens in these patients.
- Correlate, preliminarily, transdermal administration of these vaccines with the recruitment and maturation of epidermal Langerhans cells in these patients.
- Determine, preliminarily, the effects of timing of subsequent vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51, administered intradermally and subcutaneously, on the persistence of immune response in these patients.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccine therapy comprising multi-epitope melanoma peptides (MP), tetanus toxoid helper peptide (TET), and sargramostim (GM-CSF) emulsified in Montanide ISA-51 transdermally (TD) on days 1, 8, and 15. Patients then receive the vaccine intradermally (ID) and subcutaneously (SC) on days 29, 50, 71, 92, 113, and 134.
- Arm II: Patients receive vaccine therapy as in arm I. Patients also receive imiquimod topically on days 0, 7, and 14.
- Arm III: Patients receive vaccine therapy comprising MP, TET, GM-CSF, and dimethyl sulfoxide TD on days 1, 8, and 15. Patients then receive vaccine therapy comprising MP, TET, and GM-CSF emulsified in Montanide ISA-51 ID and SC on days 29, 50, 71, 92, 113, and 134.
- Arm IV: Patients receive vaccine therapy as in arm III and imiquimod as in arm II.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
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
- 12 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed melanoma
- •Stage II-IV disease
- •Has undergone surgical resection within the past 12 months
- •No clinical or radiological evidence of disease after surgical resection
- •Must have ≥ 1 undissected axillary and/or inguinal lymph node basin
- •HLA-A1, -A2, or -A3 positive
- •Ineligible for OR refused interferon
- •PATIENT CHARACTERISTICS:
- •12 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 9 g/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 times ULN
- •Lactic dehydrogenase ≤ 1.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Hepatitis C negative
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •Immunologic
- •HIV negative
- •No known or suspected allergy to any component of the study vaccines
- •No autoimmune disorder with visceral involvement
- •No prior active autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- •The following immunologic conditions are allowed:
- •Laboratory evidence of autoimmune disease (e.g., positive anti-nuclear antibody titer) without symptoms
- •Clinical evidence of vitiligo
- •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
- •Hemoglobin A1C < 7% (for patients with diabetes)
- •No medical contraindication or potential problem that would preclude study compliance
- •No known active addiction to alcohol or drugs
- •No recent (within the past year) or ongoing illicit IV drug use
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior vaccinations that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago
- •Prior multi-epitope melanoma peptide vaccine that resulted in a negative immune response allowed
- •More than 4 weeks since prior and no concurrent interferon (e.g., Intron-A®), interleukins (e.g., Proleukin®), or growth factors (e.g., Procrit®, Aranesp®, or Neulasta®)
- •More than 4 weeks since prior and no concurrent allergy desensitization injections
- 另有 17 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety if less than 33% of patients experience a dose-limiting at day 22
次要结局
- Immune response by Elispot assay at day 22
研究者
Craig L Slingluff, Jr
Professor, Department of Surgery
University of Virginia
研究点 (1)
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