IM-862 in Treating Patients With Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00003773|
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : May 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: oglufanide disodium||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Official Title:||Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer|
|Study Start Date :||February 1999|
|Primary Completion Date :||July 2000|
|Study Completion Date :||August 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003773
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Study Chair:||Agustin Garcia, MD||University of Southern California|