Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058227
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2003-04-07
Brief Title:
Alvocidib Fludarabine Phosphate and Rituximab in Treating Patients With Lymphoproliferative Disorders or Mantle Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Flavopiridol Fludarabine and Rituximab in Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 I trial studies the side effects best way to give and the best dose of alvocidib when given together with fludarabine phosphate and rituximab in treating patients with previously untreated or relapsed lymphoproliferative disorders or mantle cell lymphoma Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as alvocidib and fludarabine use different ways to stop cancer cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine a safe and tolerated dose of flavopiridol alvocidib in combination with standard dose rituximab and fludarabine fludarabine phosphate in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
II To assess the toxicity of the combination regimen of flavopiridol rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
III To determine the safety toxicity and efficacy of administering flavopiridol as a 30-minute bolus followed by 4-hour infusion in combination with rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
SECONDARY OBJECTIVES
I To determine pharmacokinetics of the combination regimen of flavopiridol rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
II To determine pharmacodynamics of the combination regimen of flavopiridol rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
OUTLINE This is a dose-escalation study of alvocidib
Patients receive fludarabine phosphate intravenously IV over 15-30 minutes on days 1-5 and rituximab IV over 3-4 hours on day 1 Alvocidib is administered IV over 60 minutes on day 1 in cohort 1 on days 1 and 2 in cohort 2 and on days 1 2 and 3 in cohort 3 In cohorts 4 and 5 patients receive fludarabine phosphate and rituximab as above and alvocidib IV over 30 minutes and then IV over 4 hours on day 1 of courses 2-6 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
I To determine a safe and tolerated dose of flavopiridol alvocidib in combination with standard dose rituximab and fludarabine fludarabine phosphate in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
II To assess the toxicity of the combination regimen of flavopiridol rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
III To determine the safety toxicity and efficacy of administering flavopiridol as a 30-minute bolus followed by 4-hour infusion in combination with rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
SECONDARY OBJECTIVES
I To determine pharmacokinetics of the combination regimen of flavopiridol rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
II To determine pharmacodynamics of the combination regimen of flavopiridol rituximab and fludarabine in patients with indolent B-cell lymphoproliferative disorders and mantle cell lymphoma
OUTLINE This is a dose-escalation study of alvocidib
Patients receive fludarabine phosphate intravenously IV over 15-30 minutes on days 1-5 and rituximab IV over 3-4 hours on day 1 Alvocidib is administered IV over 60 minutes on day 1 in cohort 1 on days 1 and 2 in cohort 2 and on days 1 2 and 3 in cohort 3 In cohorts 4 and 5 patients receive fludarabine phosphate and rituximab as above and alvocidib IV over 30 minutes and then IV over 4 hours on day 1 of courses 2-6 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
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 | None | httpsreporternihgovquickSearchU01CA076576 |
| OSU 0211 | None | None | None |
| OSU-02H0281 | None | None | None |
| CDR0000287196 | None | None | None |
| NCI-5745 | None | None | None |
| OSU-0211 | None | None | None |