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A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer (NCT00003890)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors.
  • Drug: MG 98
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.

    - Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.

    - Evaluate the effectiveness of this treatment regimen in these patients.

    OUTLINE: This is a dose escalation, multicenter study.

    Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

    The dose of MG98 is escalated in cohorts of 1-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

    Patients are followed at week 4, then at least every 3 months until relapse of disease.

    PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 10-12 months.

    2 locations

    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1999
    Updated:
    06 November, 2010
    Participants:
    20
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