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Brief Title: BMS-214662 in Treating Patients With Solid Tumors
Official Title: Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors
Study ID: NCT00005973
Brief Summary: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors. II. Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients. III. Determine the nature of dose limiting toxicity of this drug in this patient population. IV. Determine the recommended phase II regimen of this drug in these patients. V. Establish a pharmacologic and pharmacokinetic profile of this drug in these patients. OUTLINE: This is a dose escalation study. Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for at least 24 months.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Vassiliki Papadimitrakopoulou
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR