A Phase I Trial of Recombinant Human Interleukin-12 After High-Dose Therapy and Autologous Hematopoietic Stem Cell Support
OBJECTIVES: I. Assess the safety and maximum tolerated dose of interleukin-12 (IL-12) in
patients with hematologic malignancies or solid tumors who have undergone high-dose
chemotherapy and autologous stem cell transplantation. II. Evaluate the hematologic and
immunologic effects of IL-12 in these patients.
OUTLINE: This is a dose-escalation study. Patients receive interleukin-12 (IL-12) IV as a
single test dose followed by 2 weeks of rest. Patients then receive IL-12 IV daily for 5
days followed by 16 days of rest for up to 6 courses. Cohorts of 3-5 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 5 patients experience dose-limiting
toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Primary Purpose: Treatment
Michael J. Robertson, MD
Indiana University Melvin and Bren Simon Cancer Center
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|