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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00082784
Other study ID # NCI-2009-00058
Secondary ID NCI-2009-00058CD
Status Completed
Phase Phase 1
First received May 14, 2004
Last updated December 22, 2014
Start date March 2004
Est. completion date September 2014

Study information

Verified date October 2014
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date September 2014
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms

  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • 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

Intervention

Drug:
Bortezomib
Given IV
Alvocidib Hydrochloride
Given IV
Other:
Pharmacological Study
Correlative studies

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States University of Pittsburgh Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recommended phase II dose 21 days Yes
Secondary Maximum tolerated dose, assessed according to NCI CTCAE v4.0 21 days Yes
Secondary Response Up to 8 years No
Secondary Response duration Up to 8 years No
Secondary Time to progression Up to 8 years No
Secondary Survival Up to 8 years No
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