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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue

Nodal Marginal Zone Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief 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 di...

Detailed Description

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 dete...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2014

    Estimated Enrollment :

    93 Patients enrolled

    Trial Details

    Trial ID

    NCT00082784

    Start Date

    March 1 2004

    End Date

    September 1 2014

    Last Update

    December 23 2014

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Moffitt Cancer Center

    Tampa, Florida, United States, 33612

    2

    University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, United States, 15232

    3

    University of Pittsburgh

    Pittsburgh, Pennsylvania, United States, 15232

    4

    Medical University of South Carolina

    Charleston, South Carolina, United States, 29425