A Phase I Trial of An Admixture of Recombinant Vaccinia Virus That Express DF3/MUC1 and rV-TRICOM (B7.ICAM-1, and LFA-3) in Patients With Metastatic Adenocarcinoma of The Breast
I. To assess the toxicity associated with repeated vaccination with an admixture of
recombinant vaccinia viruses (rV-MUC-1 and rV-TRICOM).
II. To determine the maximum tolerated dose (MTD) of rV-MUC-1 and rV-TRICOM vaccine
III. To evaluate the toxicity of adding GM-CSF to the admixture of the rV-MUC-1 and
I. To assess host immune reactivity following rV-MUC-1 and rV-TRICOM with and without GM-CSF
II. To determine whether vaccination with rV-MUC-1 and rV-TRICOM with and without GM-CSF is
associated with antitumor activity.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant
vaccinia-TRICOM vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-MUC-1 and
recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Once the MTD is determined, an additional 10 patients (including 5
HLA-A2-positive patients) receive vaccination as above at the MTD and sargramostim (GM-CSF)
subcutaneously on days 1-4 and 29-32.
Patients are followed at 4 weeks, monthly until disease progression, and then annually for
up to 15 years.
PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study within 18-24
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose level preceding the dose in which 2 out of 6 patients experience dose limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Toxicity Criteria version 2.0
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|