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Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule (NCT00003985)

RATIONALE: Biological therapies such as KRN7000 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of KRN7000 in treating patients who have solid tumors that have not responded to previous treatment.
  • Drug: KRN7000
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    OBJECTIVES: I. Determine the safety profile and maximum tolerated dose of KRN7000 in patients with solid tumors. II. Assess the biological and immunological parameters that would suggest the optimal biologically active dose of KRN7000 in these patients. III. Determine the pharmacokinetics of KRN7000 at the different dose levels in these patients. IV. Measure any antitumor activity in these patients treated with this regimen.

    OUTLINE: This is a dose escalation study. Patients receive KRN7000 by slow intravenous injection on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of KRN7000 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicity.

    PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 18 months.

    27 locations

    31 August, 1998
    09 July, 2012
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