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Phase I Study of Escalating Doses of IM-862 in Patients With Ovarian Cancer (NCT00003773)

National Cancer Institute (NCI)
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.
  • Drug: oglufanide disodium
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    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.

    1 locations

    United States (1)
    • USC/Norris Comprehensive Cancer Center
      Los Angeles, California, United States, 90033-0800
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1999
    Updated:
    19 May, 2014
    Participants:
    43
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