Phase I Dose Finding Study of Anhydrovinblastine Administered as a 1-Hour Infusion Every 3 Weeks to Patients With Advanced Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose and assess the toxicity of
anhydrovinblastine in patients with advanced refractory solid tumors. II. Assess the safety,
pharmacokinetics, and efficacy of this treatment regimen in this patient population.
OUTLINE: This is a dose escalation study. Patients receive anhydrovinblastine IV over 1 hour
on day 1. Courses are repeated every 3 weeks. Treatment continues in the absence of disease
progression or unacceptable toxicity. The dose of anhydrovinblastine is escalated in cohorts
of 1-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose that at which no more than 2 of 6 patients experience dose limiting toxicity.
Patients are followed at 1 month after treatment, and then monthly until death.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 8 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Nithya Ramnath, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|