Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012181
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2001-03-03
Brief Title:
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF FLAVOPIRIDOL NSC 649890 IND 46211 IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
Status:
COMPLETED
Status Verified Date:
2013-07
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:
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas
II Determine the toxic effects and pharmacokinetics of this drug in these patients
III Determine the antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3 to 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
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 18 months
I Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas
II Determine the toxic effects and pharmacokinetics of this drug in these patients
III Determine the antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3 to 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
Patients are followed every 6 months
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| U01CA097452 | NIH | None | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0017 | None | None | None |
| CCG-AO972 | None | None | None |
| CDR0000068491 | None | None | None |
| COG-ADVL0017 | None | None | None |
| NCI-A0972 | None | None | None |