Phase I Trial of Twice Weekly IV IL-12 Plus Low-Dose Subcutaneous IL-2 in Patients With Advanced Malignancies
I. To determine the toxicity profile and MTD of low-dose SC IL-2 administered in conjunction
with BIW regimen of IV rhIL-12.
II. To determine the antitumor effects of combination therapy with IV rhIL-12 and SC IL-2.
III. To determine the impact low-dose SC IL-2 has on the magnitude and duration of in vivo
immune activation induced by a BIW schedule of IV rhIL-12.
OUTLINE: This is a dose-escalation study.
Patients receive interleukin-12 (IL-12) IV on days 1 and 4 for 6 weeks. Beginning on day 4
of the third week, patients receive interleukin-2 (IL-2) subcutaneously 1 hour before and 20
hours after each dose of IL-12. On subsequent courses, IL-2 and IL-12 are administered on
days 1 and 4 of each week. Treatment continues for 6 weeks in the absence of disease
progression or unacceptable toxicity. Patients with disease response may continue treatment
until complete response or disease progression.
Cohorts of 3-6 patients receive escalating doses of IL-12 and IL-2 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 at 3 weeks.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose level that is just below the dose on which at least 2 of 6 patients developed a dose-limiting toxicity (DLT) as assessed by CTC version 2.0
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|