Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082784
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2004-05-14
Brief Title:
Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of Bortezomib PS-341 NSC 681239 and Alvocidib Flavopiridol NSC 649890 in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Status:
COMPLETED
Status Verified Date:
2014-10
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:
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as flavopiridol work in different ways to stop cancer cells from dividing so they stop growing or die Bortezomib may increase the effectiveness of flavopiridol by making cancer cells more sensitive to the drug Giving bortezomib together with flavopiridol may kill more cancer cells This phase I trial is studying the side effects and best dose of bortezomib and flavopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms
Detailed Description:
PRIMARY OBJECTIVES
I To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms
SECONDARY OBJECTIVES
I To determine the toxic effects and maximum tolerated dose of this regimen in these patients
II To determine disease-related effects of this regimen in these patients III To determine the pharmacodynamics of this regimen in patients with myeloma
IV To determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1 4 8 and 11
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms
SECONDARY OBJECTIVES
I To determine the toxic effects and maximum tolerated dose of this regimen in these patients
II To determine disease-related effects of this regimen in these patients III To determine the pharmacodynamics of this regimen in patients with myeloma
IV To determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1 4 8 and 11
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM00100 | NIH | CTEP | httpsreporternihgovquickSearchN01CM00100 |
| NCI-2009-00058 | REGISTRY | None | None |
| CDR0000360816 | None | None | None |
| MCC 6413 | None | None | None |
| MCC-6413 | OTHER | None | None |
| 6413 | OTHER | None | None |
| R21CA110953 | NIH | None | None |
| P30CA076292 | NIH | None | None |