Overview

Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Alvocidib
Bortezomib
Criteria
Inclusion Criteria:

- 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