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

Trial Information

Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in 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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase II dose

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Steven Grant

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00058

NCT ID:

NCT00082784

Start Date:

March 2004

Completion Date:

Related Keywords:

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell 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 Multiple Myeloma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Neoplasms
Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Mantle-Cell

Name	Location
H. Lee Moffitt Cancer Center and Research Institute	Tampa, Florida 33612
Medical University of South Carolina	Charleston, South Carolina 29425-0721
University of Pittsburgh Cancer Institute	Pittsburgh, Pennsylvania 15213
Virginia Commonwealth University	Richmond, Virginia

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Trial Information

Inclusion Criteria:

Type of Study:

Study Design:

Outcome Measure:

Outcome Time Frame:

Safety Issue:

Principal Investigator

Investigator Role:

Investigator Affiliation:

Authority:

Study ID:

NCT ID:

Start Date:

Completion Date:

Related Keywords:

Name

Location