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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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

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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 InstituteTampa, Florida  33612
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Virginia Commonwealth UniversityRichmond, Virginia