Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)]
GI-6207 · 1 trial · 1 indication
NCI developed an equation based on the assumption that the change of a tumor's quantity during therapy results from 2 independent component processes: an exponential (first-order kinetics) decrease/regression and an exponential regrowth of the tumor. The equation is f(t) = exp(-d\*t)+exp(g\*t) (A) where exp is the base of the natural logarithm, and f(t) is the MTC calcitonin measurement at time t in days, divided by the tumor measurement at day 0, the time at which treatment is commenced. Rate decay constant d (days\^(-1) )represents the exponential decrease of the tumor marker signal during therapy. Rate growth constant g (days-\^(1) )represents the exponential growth of the tumor during treatment. For each patient an attempt to fit Equation (A) to each data set for which more than one data point is available. Linear regressions to evaluate the relationship between the growth rate constant,g, or other parameters will be implemented using the polynomial linear routine of Sigmaplot 9.0.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | GI-6207 for 1 year |
| B | EXPERIMENTAL | 6 months of surveillance followed by GI-6207 for 1 year |
| Name | Type | Description |
|---|---|---|
| GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)] | BIOLOGICAL | GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product. |
* INCLUSION CRITERIA: Participants must meet the following criteria for participation: * Diagnosis: Patients must have histologically confirmed medullary thyroid cancer by the Laboratory of Pathology or a pathology report and history consistent with medullary thyroid cancer. It is not uncommon for...