Brief Title
Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
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
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.
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Recommended phase II dose
Secondary Outcome
Maximum tolerated dose, assessed according to NCI CTCAE v4.0
Condition
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Intervention
Bortezomib
Study Arms / Comparison Groups
Treatment
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
93
Start Date
March 2004
Completion Date
September 2014
Primary Completion Date
October 2012
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Steven Grant, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00082784
Organization ID
NCI-2009-00058
Secondary IDs
NCI-2009-00058
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Steven Grant, Principal Investigator, Moffitt Cancer Center
Verification Date
October 2014