NCT00023634终止1 期
An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 13
- 主要终点
- toxicity
研究概览
简要总结
RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill cancer cells.
PURPOSE: This phase I trial is studying two different vaccines to treat patients who have gastric, prostate, or ovarian cancer.
详细描述
OBJECTIVES:
- Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer.
- Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients.
- Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant.
OUTLINE: Patients are assigned to one of two treatment arms.
- Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly.
- Arm II: Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly.
Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of one the following:
- •Stage II-IV gastric cancer
- •Stage IIC-IV ovarian cancer in first complete remission
- •CA 125 normal and stable*
- •Grade III anaplastic astrocytoma
- •Stage IV (M1) prostate adenocarcinoma
- •No small cell variations
- •No biochemical progression after definitive surgery, defined by the following:
- •Prostate-specific antigen more than 0.4 ng/mL which remains elevated on 2 additional measurements at least 2 weeks apart after prostatectomy
- •Three consecutive rises in PSA, each at least 1 month apart after definitive radiotherapy
- •Must be receiving androgen blockade
- •PSA less than 5 ng/mL and stable*
- •Documented EGFRvIII expression in primary tumor
- •Must have received prior surgery and or chemoradiotherapy for disease (except prostate cancer patients) NOTE: *Stable defined as no increase over 2 measurements at least 28 days apart with the last measurement within the past 28 days
- •PATIENT CHARACTERISTICS:
- •80 and under
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •SGOT no greater than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •No hepatitis
- •Not specified
- •No other malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- •No contraindication to receiving sargramostim (GM-CSF) or KLH-based vaccine products
- •No autoimmune disease
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 1 month since prior cytotoxic chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •At least 1 month since prior treatment dose corticosteroids
- •No concurrent corticosteroids
- •Radiotherapy:
- •See Disease Characteristics
- •No concurrent radiotherapy
- •See Disease Characteristics
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
EGFR vaccine with GMCSF
Experimental
EGFR antisense DNA 500 mcg peptide w/GMCSF monthly x 6 m
干预措施: GMCSF (Biological)
EGFR vaccine with KLH
Experimental
EGFR antisense DNA 500 mcg peptide w/KLH monthly x 6 m
干预措施: KLH (Biological)
结局指标
主要结局
toxicity
时间窗: during treatment
次要结局
未报告次要终点
研究者
研究点 (13)
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