Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Completed · Phase 1
Conditions studied: Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Nodal Marginal Zone Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Refractory Plasma Cell Myeloma, Splenic Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
In brief
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.
Key facts
- Study ID
- NCT00082784
- Run by
- National Cancer Institute (NCI)
- People needed
- 93
- Starts
- 2004-03-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2014-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- WBC < 50,000/mm\^3 for patients with circulating tumor cells
- No prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone
- No neuropathy >= grade 2
- No other condition that would preclude study participation
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study participation
- Prior autologous stem cell transplantation is allowed
- No prior allogeneic stem cell transplantation
- No other concurrent anticancer agents
- No other concurrent investigational agents
- Hemoglobin >= 8 g/dL
- Platelet count >= 100,000/mm\^3
- Absolute neutrophil count >= 1,500/mm\^3
- Bilirubin =< 2 times upper limit of normal (ULN)
- AST/ALT =< 3 times ULN
- Creatinine =< 2 times ULN or Creatinine clearance >= 50 mL/min
Where it is running
- 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
Full record on ClinicalTrials.gov
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