Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Study Details
Study Description
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 |
---|---|---|
|
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Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms.
SECONDARY OBJECTIVES:
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To determine the toxic effects and maximum tolerated dose of this regimen in these patients.
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To determine disease-related effects of this regimen in these patients. III. To determine the pharmacodynamics of this regimen in patients with myeloma.
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
Other: Pharmacological Study
Correlative studies
Other Names:
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Outcome Measures
Primary Outcome Measures
- Recommended phase II dose [21 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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WBC < 50,000/mm^3 for patients with circulating tumor cells
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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
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No neuropathy >= grade 2
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No other condition that would preclude study participation
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Not pregnant or nursing
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Fertile patients must use effective contraception during and for 3 months after study participation
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Prior autologous stem cell transplantation is allowed
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No prior allogeneic stem cell transplantation
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No other concurrent anticancer agents
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No other concurrent investigational agents
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Hemoglobin >= 8 g/dL
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Platelet count >= 100,000/mm^3
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Absolute neutrophil count >= 1,500/mm^3
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Bilirubin =< 2 times upper limit of normal (ULN)
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AST/ALT =< 3 times ULN
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Creatinine =< 2 times ULN or Creatinine clearance >= 50 mL/min
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
2 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15232 |
3 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15232 |
4 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
5 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Steven Grant, Moffitt Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2009-00058
- NCI-2009-00058
- CDR0000360816
- MCC 6413
- MCC-6413
- 6413
- R21CA110953
- P30CA076292
- N01CM00100