A Phase I Trial of Herceptin and Interleukin-12
I. Determine the maximum tolerated dose of interleukin-12 (IL-12) when combined with
trastuzumab in patients with HER2-Neu overexpressing malignancies.
II. Determine the safety of this regimen in these patients.
III. Analyze any expression of interferon-inducible genes in tumor tissues of these patients
after receiving this regimen.
IV. Characterize natural killer cytokine production in patients treated with this regimen.
V. Determine serum interferon gamma levels in patients treated with this regimen.
This is a dose escalation study of interleukin-12 (IL-12).
Patients receive an initial loading dose of trastuzumab IV over 90 minutes on day 1 of the
first week and a maintenance dose of trastuzumab IV over 30-90 minutes on day 1 of each
subsequent week. Patients receive IL-12 IV on days 2 and 5 beginning on week 3. Treatment
with maintenance trastuzumab and IL-12 repeats weekly for 14 weeks in the absence of disease
progression or unacceptable toxicity. Patients with stable or responding disease continue
treatment for up to 38 additional weeks.
Cohorts of 3-6 patients receive escalating doses of IL-12 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity.
Patients are followed every 3 months for 1 year and then every 6 months thereafter for
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 2.0 (CTCAE v2.0)
Up to 52 weeks
Ohio State University
United States: Food and Drug Administration
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