) 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.
| Chatterjee, S K; Tripathi, P K; Chakraborty, M et al. (1998) Molecular mimicry of carcinoembryonic antigen by peptides derived from the structure of an anti-idiotype antibody. Cancer Res 58:1217-24 |
