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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00082784
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue 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 Drug: Bortezomib Drug: Alvocidib Hydrochloride Other: Pharmacological Study Phase 1

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Study Start Date : March 2004
Actual Primary Completion Date : October 2012
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
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.
 Drug: Bortezomib
Given IV

Drug: Alvocidib Hydrochloride
Given IV
Other Names:
  • FLAVO
  • HL-275
  • HMR 1275

Other: Pharmacological Study
Correlative studies
Other Name: pharmacological studies


Outcome Measures
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Primary Outcome Measures :
  1. Recommended phase II dose [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Maximum tolerated dose, assessed according to NCI CTCAE v4.0 [ Time Frame: 21 days ]
  2. Response [ Time Frame: Up to 8 years ]
  3. Response duration [ Time Frame: Up to 8 years ]
  4. Time to progression [ Time Frame: Up to 8 years ]
  5. Survival [ Time Frame: Up to 8 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082784


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven Grant Moffitt Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082784    
Other Study ID Numbers: NCI-2009-00058
NCI-2009-00058 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000360816
MCC 6413
MCC-6413 ( Other Identifier: Moffitt Cancer Center )
6413 ( Other Identifier: CTEP )
R21CA110953 ( U.S. NIH Grant/Contract )
P30CA076292 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Multiple Myeloma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
 Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bortezomib
Alvocidib
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors