Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303953
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2006-03-15
Brief Title:
PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of PXD101 NSC-726630 in Relapsed and Refractory Aggressive B-Cell Lymphomas
Status:
COMPLETED
Status Verified Date:
2013-04
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 II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma treated with PXD101
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients II Estimate the 6-month progression-free survival rate in patients treated with this drug
TERTIARY OBJECTIVES
I Determine the major histocompatability complex of class II proteins HLA-DR -DP -DQ TUNEL and CD8 infiltration status by immunochemistry on paired pre- and post-treatment tumor samples in the first 20 patients enrolled
II Measure CIITA and HLA-DR mRNA expression using quantitative reverse transcriptase-polymerase chain reaction and determine preliminarily the associations of these markers with progression-free survival
III Evaluate paired pre- and post-treatment peripheral blood mononuclear cells from patients for histone acetylation status and determine correlation with findings from duplicate experiments on pre- and post-needle core biopsies
OUTLINE This is a multicenter study
Patients receive PXD101 IV over 30 minutes on days 1-5 Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Needle core biopsies and peripheral blood mononuclear cells are obtained from the first 20 patients pre- and post-treatment for biomarker correlative studies
After completion of study treatment patients are followed every 3-6 months for up to 3 years
I Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma treated with PXD101
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients II Estimate the 6-month progression-free survival rate in patients treated with this drug
TERTIARY OBJECTIVES
I Determine the major histocompatability complex of class II proteins HLA-DR -DP -DQ TUNEL and CD8 infiltration status by immunochemistry on paired pre- and post-treatment tumor samples in the first 20 patients enrolled
II Measure CIITA and HLA-DR mRNA expression using quantitative reverse transcriptase-polymerase chain reaction and determine preliminarily the associations of these markers with progression-free survival
III Evaluate paired pre- and post-treatment peripheral blood mononuclear cells from patients for histone acetylation status and determine correlation with findings from duplicate experiments on pre- and post-needle core biopsies
OUTLINE This is a multicenter study
Patients receive PXD101 IV over 30 minutes on days 1-5 Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Needle core biopsies and peripheral blood mononuclear cells are obtained from the first 20 patients pre- and post-treatment for biomarker correlative studies
After completion of study treatment patients are followed every 3-6 months for up to 3 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 |
|---|---|---|---|
| NCI-2009-01096 | REGISTRY | None | None |
| CDR0000462614 | None | None | None |
| S0520 | OTHER | None | None |
| S0520 | OTHER | None | None |
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |