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Phase I Trial of PS-341 in Advanced Cancers (NCT00004002)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment.
  • Drug: bortezomib
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of PS-341 in patients with advanced solid tumors or lymphoma. II. Evaluate the pharmacodynamics of this drug by measuring 20S proteasome inhibition in these patients. III. Assess changes in P53 or P27, and possibly E2F-1 and cyclin E, in patients with lymphoma in response to this drug. IV. Evaluate objective tumor response to this drug in these patients. V. Evaluate the relationship between toxicity and 20S proteasome inhibition in blood and in accessible tumor tissue in these patients. VI. Evaluate response to treatment with this drug in patients with measurable or evaluable disease.

    OUTLINE: This is a dose-escalation, multicenter study. Patients receive PS-341 IV on days 1 and 4. Treatment repeats every 14 days for at least 2 courses in the absence of unacceptable toxicity or disease progression. Patients with stable or responding disease may receive additional courses at the discretion of the treating physician. Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks.

    PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.

    5 locations

    United States (5)
    • Massachusetts General Hospital Cancer Center
      Not specified
      Boston, Massachusetts, United States, 02114
    • Brigham and Women's Hospital
      Not specified
      Boston, Massachusetts, United States, 02115
    • Dana-Farber Cancer Institute
      Not specified
      Boston, Massachusetts, United States, 02115
    • Beth Israel Deaconess Medical Center
      Not specified
      Boston, Massachusetts, United States, 02215
    • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      Not specified
      New York, New York, United States, 10016
    30 June, 1999
    07 November, 2012
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