Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
8 other identifiers
interventional
93
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2004
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 14, 2004
CompletedFirst Posted
Study publicly available on registry
May 19, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 23, 2014
October 1, 2014
8.6 years
May 14, 2004
December 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Recommended phase II dose
21 days
Secondary Outcomes (5)
Maximum tolerated dose, assessed according to NCI CTCAE v4.0
21 days
Response
Up to 8 years
Response duration
Up to 8 years
Time to progression
Up to 8 years
Survival
Up to 8 years
Study Arms (1)
Treatment
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Grant
Moffitt Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2004
First Posted
May 19, 2004
Study Start
March 1, 2004
Primary Completion
October 1, 2012
Study Completion
September 1, 2014
Last Updated
December 23, 2014
Record last verified: 2014-10