Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019344
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Flavopiridol in Treating Patients With Refractory Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
Status:
COMPLETED
Status Verified Date:
2002-05
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of flavopiridol in treating patients who have refractory cancer
PURPOSE Phase I trial to study the effectiveness of flavopiridol in treating patients who have refractory cancer
Detailed Description:
OBJECTIVES I Determine the dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with refractory solid tumors or lymphoma 2 Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study Patients receive flavopiridol IV over 1 hour on day 1 Treatment continues every 3 weeks in the absence of disease progression A cohort of 3-6 patients receives treatment at each dose level of flavopiridol If dose-limiting toxicity DLT occurs in no more than 1 of 6 patients subsequent cohorts of 6 patients each receive escalating doses of drug on the same schedule Intrapatient dose escalation to the next level is permitted in the absence of DLT
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study within 27 months
OUTLINE This is a dose-escalation study Patients receive flavopiridol IV over 1 hour on day 1 Treatment continues every 3 weeks in the absence of disease progression A cohort of 3-6 patients receives treatment at each dose level of flavopiridol If dose-limiting toxicity DLT occurs in no more than 1 of 6 patients subsequent cohorts of 6 patients each receive escalating doses of drug on the same schedule Intrapatient dose escalation to the next level is permitted in the absence of DLT
PROJECTED ACCRUAL Approximately 36 patients will be accrued for this study within 27 months
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 |
|---|---|---|---|
| NCI-T97-0064 | None | None | None |
| NCI-97-C-0171C | None | None | None |