IM-862 in Treating Patients With Recurrent Ovarian Cancer
RATIONALE: IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of IM-862 in treating patients who have recurrent ovarian cancer after treatment with chemotherapy and surgery.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer|
|Study Start Date:||February 1999|
|Study Completion Date:||August 2001|
|Primary Completion Date:||July 2000 (Final data collection date for primary outcome measure)|
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.
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Study Chair:||Agustin Garcia, MD||University of Southern California|