COMPARISON OF ALUM AND QS 21 BASED ANTI ID VACCINES

描述：（申请人描述）我们开发了一种抗独特型 命名为3 H1的抗体是CEA的内部图像。 我们有 在先前的试验中证明，超过80%的晚期乳腺癌患者 用氢氧化铝沉淀的抗独特型治疗结直肠癌 抗体3 H1产生主动体液免疫和T细胞增殖 对CEA的回应 毒性很小，主要与局部 轻微发热和疲劳的反应。 我们还展示了一个更 最近的试验表明，接受5 FU和左旋咪唑治疗的患者， 对3 H1抗体有良好的免疫应答。 在当前的试验中，我们将 比较我们的3 H1抗独特型抗体（2 mg）作为 氢氧化铝沉淀以及2 mg与QS-21佐剂混合。 在我们之前的试验中，我们没有研究溶细胞性T淋巴细胞， 试验中，我们将比较溶细胞性T淋巴细胞反应以及 两个治疗组中的体液免疫应答。 预计各国 QS-21是一种较好的刺激溶细胞性T淋巴细胞的佐剂 应答 将对患者进行复发性疾病的随访， 在没有复发疾病的情况下，可延长至2年。 这次审判将决定 制备3 H1用于多机构III期试验 对于患有杜克B和C结直肠癌的患者。

DESCRIPTION: (Applicant's Description) We have developed an anti-idiotype antibody designated 3H1 that is the internal image of CEA. We have demonstrated in a prior trial that over 80 percent of patients with advanced colorectal cancer treated with aluminum hydroxide precipitated anti-idiotype antibody 3H1 generated active humoral immunity and T cell proliferative response to CEA. Toxicity has been minimal, primarily related to local reactions with mild fever and fatigue. We also demonstrated in a more recent trial that patients who are treated with 5FU and levamisole have an excellent immune response to 3H1 antibody. In the current trial, we will compare the immune response of our 3H1 anti-idiotype antibody (2 mg) as an aluminum hydroxide precipitate as well as 2 mg mixed with QS-21 adjuvant. In our prior trial we did not study cytolytic T lymphocytes and in this trial we will compare the cytolytic T lymphocyte responses as well as the humoral immune responses in both treatment arms. It is anticipated that QS-21 will be a better adjuvant for stimulating cytolytic T lymphocyte responses. Patients will be followed for recurrent disease and treated up to two years in the absence of recurrent disease. This trial will determine the preparation of 3H1 to be used in a multi-institutional phase III trials for patients with Duke B and C colorectal cancer.