Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of IM-862 administered intranasally in
patients with recurrent ovarian cancer. II. Determine the toxicity of this regimen in this
patient population. III. Obtain preliminary data regarding the efficacy of this drug in
these patients. IV. Evaluate the effect of this drug in serum levels of vascular endothelial
growth factor and transforming growth factor in this population.
OUTLINE: This is a dose escalation study. Patients receive IM-862 intranasally daily.
Treatment continues for 6 months in the absence of unacceptable toxicity or disease
progression. At the physician's discretion, further treatment may be given if the patient is
still responding after 6 months of treatment. The dose of IM-862 is escalated in cohorts of
10-20 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose preceding that at which 3 of 10 or 5 of 20 patients experience dose limiting
toxicity.
PROJECTED ACCRUAL: A total of 20-70 evaluable patients will be accrued for this study within
6-9 months.
Interventional
Primary Purpose: Treatment
Agustin Garcia, MD
Study Chair
USC/Norris Comprehensive Cancer Center
United States: Federal Government
CDR0000066900 (5O-98-4)
NCT00003773
February 1999
August 2001
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |