Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112684
Status:
TERMINATED
Last Update Posted:
2014-02-24
First Post:
2005-06-02
Brief Title:
Alvocidib in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Flavopiridol in Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2011-11
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 is studying the side effects and best dose of alvocidib in treating patients with locally advanced or metastatic solid tumors Drugs used in chemotherapy such as alvocidib work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Alvocidib may also stimulate the immune system in different ways and stop tumor cells from growing It may also stop the growth of solid tumors by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the toxicity profile and dose-limiting toxicity of flavopiridol alvocidib in patients with locally advanced or metastatic solid tumors
II Determine the maximum tolerated dose of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
II Determine the immunomodulatory effects of this drug in these patients III Determine pharmacogenomics of this drug using peripheral blood mononuclear cells in patients who experience clinical response
OUTLINE This is a pilot dose-escalation study
Patients receive alvocidib intravenously IV over 4½ hours once weekly in weeks 1-4 Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable disease after 4 courses of therapy discontinue study treatment Patients who achieve complete remission CR receive 1 additional course of therapy beyond documentation of CR Cohorts of 3-6 patients receive escalating doses of alvocidib 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 A total of 10 patients are treated at the MTD
After completion of study treatment patients are followed within 4 weeks
I Determine the toxicity profile and dose-limiting toxicity of flavopiridol alvocidib in patients with locally advanced or metastatic solid tumors
II Determine the maximum tolerated dose of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
II Determine the immunomodulatory effects of this drug in these patients III Determine pharmacogenomics of this drug using peripheral blood mononuclear cells in patients who experience clinical response
OUTLINE This is a pilot dose-escalation study
Patients receive alvocidib intravenously IV over 4½ hours once weekly in weeks 1-4 Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable disease after 4 courses of therapy discontinue study treatment Patients who achieve complete remission CR receive 1 additional course of therapy beyond documentation of CR Cohorts of 3-6 patients receive escalating doses of alvocidib 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 A total of 10 patients are treated at the MTD
After completion of study treatment patients are followed within 4 weeks
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-2009-00135 | REGISTRY | None | None |
| OSU-2005C0009 | None | None | None |
| CDR0000429582 | None | None | None |
| NCI-7204 | None | None | None |
| OSU-04111 | None | None | None |
| OSU 04111 | OTHER | None | None |
| 7204 | OTHER | None | None |
| U01CA076576 | NIH | None | None |
| P30CA016058 | NIH | CTEP | httpsreporternihgovquickSearchP30CA016058 |