Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule
OBJECTIVES: I. Determine the safety profile and maximum tolerated dose of KRN7000 in
patients with solid tumors. II. Assess the biological and immunological parameters that
would suggest the optimal biologically active dose of KRN7000 in these patients. III.
Determine the pharmacokinetics of KRN7000 at the different dose levels in these patients.
IV. Measure any antitumor activity in these patients treated with this regimen.
OUTLINE: This is a dose escalation study. Patients receive KRN7000 by slow intravenous
injection on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each
receive escalating doses of KRN7000 until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 18
Primary Purpose: Treatment
Giuseppe Giaccone, MD, PhD
Free University Medical Center
United States: Federal Government