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Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving bortezomib together with flavopiridol may kill more cancer cells. This phase I trial is studying the side effects and best dose of bortezomib and flavopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms.
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms. SECONDARY OBJECTIVES: I. To determine the toxic effects and maximum tolerated dose of this regimen in these patients. II. To determine disease-related effects of this regimen in these patients. III. To determine the pharmacodynamics of this regimen in patients with myeloma. IV. To determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Moffitt Cancer Center
Tampa, Florida, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Start Date
March 1, 2004
Primary Completion Date
October 1, 2012
Completion Date
September 1, 2014
Last Updated
December 23, 2014
93
ACTUAL participants
Bortezomib
DRUG
Alvocidib Hydrochloride
DRUG
Pharmacological Study
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT06905509
NCT06859008
Data Source & Attribution
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