A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adnocarcinoma of the Breast
OBJECTIVES: I. Determine the toxicity associated with repeated vaccination with recombinant
vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) in patients with metastatic breast cancer. II.
Determine the maximum tolerated dose of rV-DF3/MUC1, based on cellular and humoral immunity,
in these patients. III. Determine whether vaccination with rV-DF3/MUC1 is associated with
antitumor activity in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive recombinant vaccinia
DF3/MUC1 vaccine (rV-DF3/MUC1) intradermally. Treatment repeats every month for 3 courses in
the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients
receive escalating doses of rV-DF3/MUC1 until the maximum tolerated dose (MTD) or the
highest dose level to be tested is reached. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6
months.
PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 1-2
years.
Interventional
Primary Purpose: Treatment
Donald W. Kufe, MD
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
CDR0000066886
NCT00003761
February 1999
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Boston Medical Center | Boston, Massachusetts 02118 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |