Phase I Trial of Interleukin-12 Followed by Interferon-Alpha
OBJECTIVES:
I. Determine the maximum tolerated dose of interferon alfa when preceded by a single dose of
interleukin-12 in patients with recurrent or metastatic melanoma or other advanced
malignancies.
OUTLINE: This is a dose-escalation study.
Cohorts of 3 patients receive interleukin-12 IV push on day 1, followed by escalating doses
of interferon alfa by subcutaneous injection at 24, 48, 72, 96 and 120 hours. Courses repeat
every 2 weeks for 6 months (12 courses total) in the absence of unacceptable toxicity and
disease progression. Patients achieving partial response or stable disease at the completion
of 6 months of therapy may receive additional courses of therapy for up to 24 months. Dose
escalation of interferon alfa continues in subsequent cohorts in the absence of dose
limiting toxicity (DLT). If 1 of 3 patients experiences DLT at a dose level, then 3
additional patients are entered at that dose level. If 2 of 6 patients experience DLT, then
dose escalation stops. The maximum tolerated dose is defined as 1 level below that dose at
which 2 or more of 6 patients experience DLT. Patients are followed every 3 months for 1
year and then every 6 months thereafter.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
William E. Carson, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-01397
NCT00003451
August 1998
Name | Location |
---|---|
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |