Recurrent Breast Cancer Clinical Trial
Official title:
Phase I Trial of Interleukin-12 in Combination With Paclitaxel Plus Herceptin in Patients With Her2-positive Malignancies
Phase I trial to study the effectiveness of interleukin-12, paclitaxel, and trastuzumab in treating patients who have solid tumors. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining interleukin-12, chemotherapy, and monoclonal antibody therapy may kill more tumor cells.
OBJECTIVES:
I. Determine the maximum tolerated dose of interleukin-12 when given in combination with
paclitaxel and trastuzumab (Herceptin®) in patients with HER2/neu-overexpressing
malignancies.
II. Determine the response rate and time to progression in patients treated with this
regimen.
III. Determine the anti-tumor effect of this regimen in these patients.
OUTLINE: This is a dose-escalation study of interleukin-12.
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15 and
paclitaxel IV over 3 hours on day 1 of course 1. Beginning with course 2, patients receive
trastuzumab and paclitaxel as in course 1 and interleukin-12 subcutaneously on days 2, 5, 9,
12, 16, and 19. Courses repeat every 21 days for up to 1 year in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 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.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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