Charleston, South Carolina 29425

  • Recur

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

NCI-2009-00058


NCT ID:

NCT00082784


Secondary ID:

NCI-2009-00058


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventio


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

93


Enrollment Type:

Actual


Overall Contact Information

Official Name:Steven Grant
Principal Investigator
Moffitt Cancer Center

Study Dates

Start Date:March 2004
Completion Date:September 2014
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:October 2014
Last Changed Date:December 22, 2014
First Received Date:May 14, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Recommended phase II dose
Time Frame:21 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Maximum tolerated dose, assessed according to NCI CTCAE v4.0
Time Frame:21 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Response
Time Frame:Up to 8 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Response duration
Time Frame:Up to 8 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to progression
Time Frame:Up to 8 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Survival
Time Frame:Up to 8 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Bortezomib
Description:Given IV
Arm Name:Treatment
Intervention Type:Drug
Name:Alvocidib Hydrochloride
Description:Given IV
Arm Name:Treatment
Other Name:FLAVO
Intervention Type:Other
Name:Pharmacological Study
Description:Correlative studies
Arm Name:Treatment
Other Name:pharmacological studies

Study Arms

Study Arm Type:Experimental
Arm Name: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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