Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098371
Status:
TERMINATED
Last Update Posted:
2016-10-24
First Post:
2004-12-07
Brief Title:
Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Flavopiridol Administered as a 30 Minute Loading Dose Followed by a 4-Hour Continuous Infusion in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From CLL
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CTEP Initiated Action
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well flavopiridol works in treating patients with chronic lymphocytic leukemia or prolymphocytic leukemia Drugs used in chemotherapy such as flavopiridol work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I To determine the complete response CR and overall response rate CR Partial Response PR of this regimen
II To assess the toxicity profile of this regimen III To examine response duration progression-free survival and overall survival following this treatment
IV To assess the pharmacokinetics of this novel schedule of administration
SECONDARY OBJECTIVES
I To determine the influence of adverse prognostic factors including interphase cytogenetics VH mutational status ZAP-70 expression CD38 and p53 mutational status with response to flavopiridol treatment
II To determine the influence of flavopiridol treatment on serial measurements of mcl-1 mRNA and protein HIF-1 mRNA and protein NF-kappaB activity IkappaB IkappaB phosphorylation GSK-beta and IL-6 down-stream targets
III To assess the relationship of drug induced apoptosis and mitochondrial perturbation of Chronic Lymphocytic Leukemia CLL cells in vitro and subsequent relationship to clinical response and tumor lysis in vivo
IV To examine cytokine levels IL-6 IFN-gamma TNF-alpha during treatment with flavopiridol
V To assess pharmacokinetics PK to determine the variability of PK and PD analyses between treatment administrations and correlation with specific Single Nucleotide Polymorphisms SNPs potentially involved in flavopiridol disposition
VI To assess differences in diagnosis and relapse samples to investigate mechanisms of acquired flavopiridol resistance in primary CLL cells
OUTLINE This is an open-label study Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1 8 15 and 22
Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving at least a partial remission PR and whose PR lasts for 6 months after completion of treatment may receive 6 additional courses of flavopiridolPatients are followed at 2 months and then every 3 months for 5 years
I To determine the complete response CR and overall response rate CR Partial Response PR of this regimen
II To assess the toxicity profile of this regimen III To examine response duration progression-free survival and overall survival following this treatment
IV To assess the pharmacokinetics of this novel schedule of administration
SECONDARY OBJECTIVES
I To determine the influence of adverse prognostic factors including interphase cytogenetics VH mutational status ZAP-70 expression CD38 and p53 mutational status with response to flavopiridol treatment
II To determine the influence of flavopiridol treatment on serial measurements of mcl-1 mRNA and protein HIF-1 mRNA and protein NF-kappaB activity IkappaB IkappaB phosphorylation GSK-beta and IL-6 down-stream targets
III To assess the relationship of drug induced apoptosis and mitochondrial perturbation of Chronic Lymphocytic Leukemia CLL cells in vitro and subsequent relationship to clinical response and tumor lysis in vivo
IV To examine cytokine levels IL-6 IFN-gamma TNF-alpha during treatment with flavopiridol
V To assess pharmacokinetics PK to determine the variability of PK and PD analyses between treatment administrations and correlation with specific Single Nucleotide Polymorphisms SNPs potentially involved in flavopiridol disposition
VI To assess differences in diagnosis and relapse samples to investigate mechanisms of acquired flavopiridol resistance in primary CLL cells
OUTLINE This is an open-label study Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1 8 15 and 22
Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving at least a partial remission PR and whose PR lasts for 6 months after completion of treatment may receive 6 additional courses of flavopiridolPatients are followed at 2 months and then every 3 months for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62207 | NIH | None | httpsreporternihgovquickSearchN01CM62207 |
| OSU 0491 | None | None | None |