Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058240
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-04-07
Brief Title:
Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose-Escalation Study of Flavopiridol NSC 649890 Administered as a 30 Minute Loading Dose Followed by a 4-Hour Infusion in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia CLLSmall Lymphocytic Lymphoma SLL
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial studies the side effects and best dose of flavopiridol in treating patients with previously treated chronic lymphocytic leukemia or lymphocytic lymphoma Drugs used in chemotherapy such as flavopiridol work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the toxicity profile dose-limiting toxicity and maximum tolerated dose of flavopiridol administered as a 30 minute loading dose followed by a 4-hour infusion once weekly for 4 consecutive weeks every 6 weeks
II To determine the safety and feasibility of performing dose escalation to 80 mgm2 30 mgm2 30-minute IV bolus followed by 50 mgm2 4-hour IV infusion beginning dose 2 in patients who do not experience severe tumor lysis requiring hemodialysis during dose 1
III To determine the pharmacokinetics and cellular pharmacodynamics of flavopiridol administered in this schedule
SECONDARY OBJECTIVES
I To determine the complete response CR and overall response rate CR PR of flavopiridol in patients with previously-treated CLL administered as a 30 minute loading dose followed by a 4 hour infusion once weekly for 4 consecutive weeks every 6 weeks
OUTLINE This is a dose-escalation study
Patients receive a loading dose of flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1 8 15 and 22 Treatment repeats every 6 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity After the MTD is determined 12 additional patients are accrued and treated as above at the recommended phase II dose
After completion of study treatment patients are followed at 2 months and then every 3 months for 2 years
I To determine the toxicity profile dose-limiting toxicity and maximum tolerated dose of flavopiridol administered as a 30 minute loading dose followed by a 4-hour infusion once weekly for 4 consecutive weeks every 6 weeks
II To determine the safety and feasibility of performing dose escalation to 80 mgm2 30 mgm2 30-minute IV bolus followed by 50 mgm2 4-hour IV infusion beginning dose 2 in patients who do not experience severe tumor lysis requiring hemodialysis during dose 1
III To determine the pharmacokinetics and cellular pharmacodynamics of flavopiridol administered in this schedule
SECONDARY OBJECTIVES
I To determine the complete response CR and overall response rate CR PR of flavopiridol in patients with previously-treated CLL administered as a 30 minute loading dose followed by a 4 hour infusion once weekly for 4 consecutive weeks every 6 weeks
OUTLINE This is a dose-escalation study
Patients receive a loading dose of flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1 8 15 and 22 Treatment repeats every 6 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity After the MTD is determined 12 additional patients are accrued and treated as above at the recommended phase II dose
After completion of study treatment patients are followed at 2 months and then every 3 months for 2 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 |
|---|---|---|---|
| U01CA076576 | NIH | CTEP | httpsreporternihgovquickSearchU01CA076576 |
| NCI-2012-01435 | REGISTRY | None | None |
| CDR0000287197 | None | None | None |
| NCI-5746 | None | None | None |
| OSU-0055 | None | None | None |
| OSU 0055 | OTHER | None | None |
| 5746 | OTHER | None | None |
| R21CA112947 | NIH | None | None |
| P30CA016058 | NIH | None | None |