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A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors (NCT00003712)

National Cancer Institute (NCI)
University of Texas
Wyeth is now a wholly owned subsidiary of Pfizer
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 CCI-779 in treating patients who have advanced solid tumors.
  • Drug: temsirolimus
    •Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity. •Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Determine the safety, tolerability, and maximum tolerated dose (MTD) of CCI-779 in patients with advanced solid tumors (part I) who are not receiving anticonvulsant therapy.

    - Determine the safety, tolerability, and MTD in patients with recurrent gliomas or brain metastases (part II) who are receiving anticonvulsant therapy.

    - Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in these patients.

    OUTLINE: This is an open-label, dose-escalation study.

    - Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

    The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity.

    - Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II.

    PROJECTED ACCRUAL: Approximately 20 patients will be accrued for part I for this study within 8 months, and 12 patients will be accrued for part II within 7 months.

    2 locations

    United States (2)
    • Mayo Clinic Cancer Center
      Rochester, Minnesota, United States, 55905
    • San Antonio Cancer Institute
      San Antonio, Texas, United States, 78229-3264
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 December, 2000
    Updated:
    06 August, 2012
    Participants:
    15
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