Phase I Trial of Interleukin-12 in Combination With Paclitaxel Plus Herceptin in Patients With Her2-positive Malignancies
I. Determine the maximum tolerated dose of interleukin-12 when given in combination with
paclitaxel and trastuzumab (Herceptin®) in patients with HER2/neu-overexpressing
II. Determine the response rate and time to progression in patients treated with this
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
MTD of IL-12, defined as the dose level one level beneath that dose at which 2 or more of 6 patients showed DLT, based on the NCI CTC version 2.0
Up to 21 days
Ohio State University
United States: Food and Drug Administration
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