Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112723
Status:
TERMINATED
Last Update Posted:
2016-08-08
First Post:
2005-06-02
Brief Title:
Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Flavopiridol Administered as a 30-Minute Bolus Followed by a 4-Hour Infusion in Lymphomas and Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively Complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial is studying the side effects and best dose of flavopiridol and to see how well it works in treating patients with lymphoma or multiple myeloma Drugs used in chemotherapy such as flavopiridol work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the disease-specific dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with relapsed or refractory lymphoma or multiple myeloma
II Determine the complete and partial response rate in patients with selected non-Hodgkins lymphoma eg indolent B-cell mantle cell intermediate grade B-cell and TNK-cell Hodgkins lymphoma or multiple myeloma treated with this drug
III Determine the qualitative and quantitative toxic effects or this drug in terms of organ specificity time course predictability and reversibility in these patients
IV Determine subsets of lymphoidplasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of this drug in these patients II Determine the effect of this drug on innate immunity including T- B- and NK-cell subsets and quantitative immunoglobulin levels in these patients
III Determine whether acute infusion toxicity eg fever hypotension tumor pain and dyspnea observed with other flavopiridol treatment schedules is related to a cytokine-release syndrome in these patients
IV Determine whether this drug induces response independent of p53 mutational status in these patients
OUTLINE This is a phase I dose-escalation study followed by a multicenter phase II pilot study Patients enrolled in the phase II portion of the study are stratified according to diagnosis
PHASE I Patients receive flavopiridol IV over 4½ hours on days 1 8 15 and 22 Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 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
PHASE II Patients receive flavopiridol as in phase I at the MTD determined in phase I
NOTE The phase II treatment dose and schedule for hairy cell leukemia patients will be adapted from that developed in previous phase II studies of flavopiridol for the treatment of chronic lymphocytic leukemia
After completion of study therapy patients are followed every 3 months for 2 years
I Determine the disease-specific dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with relapsed or refractory lymphoma or multiple myeloma
II Determine the complete and partial response rate in patients with selected non-Hodgkins lymphoma eg indolent B-cell mantle cell intermediate grade B-cell and TNK-cell Hodgkins lymphoma or multiple myeloma treated with this drug
III Determine the qualitative and quantitative toxic effects or this drug in terms of organ specificity time course predictability and reversibility in these patients
IV Determine subsets of lymphoidplasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of this drug in these patients II Determine the effect of this drug on innate immunity including T- B- and NK-cell subsets and quantitative immunoglobulin levels in these patients
III Determine whether acute infusion toxicity eg fever hypotension tumor pain and dyspnea observed with other flavopiridol treatment schedules is related to a cytokine-release syndrome in these patients
IV Determine whether this drug induces response independent of p53 mutational status in these patients
OUTLINE This is a phase I dose-escalation study followed by a multicenter phase II pilot study Patients enrolled in the phase II portion of the study are stratified according to diagnosis
PHASE I Patients receive flavopiridol IV over 4½ hours on days 1 8 15 and 22 Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 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
PHASE II Patients receive flavopiridol as in phase I at the MTD determined in phase I
NOTE The phase II treatment dose and schedule for hairy cell leukemia patients will be adapted from that developed in previous phase II studies of flavopiridol for the treatment of chronic lymphocytic leukemia
After completion of study therapy patients are followed every 3 months for 2 years
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 |
|---|---|---|---|
| P30CA016058 | NIH | CTEP | httpsreporternihgovquickSearchP30CA016058 |
| NCI-2011-01346 | REGISTRY | None | None |
| OSU-04100 | None | None | None |
| CDR0000429577 | None | None | None |
| OSU-2005C0006 | None | None | None |
| NCI-7002 | None | None | None |
| OSU 04100 | OTHER | None | None |
| 7002 | OTHER | None | None |
| U01CA076576 | NIH | None | None |
| N01CM00070 | NIH | None | None |