Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087425
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2004-07-08
Brief Title:
Bryostatin 1 and Rituximab in Treating Patients With B-Cell Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
National Institute on Aging NIA
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-cell Non Hodgkins Lymphoma And Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as bryostatin 1 work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Bryostatin 1 may help rituximab kill more cancer cells by making them more sensitive to the drug
PURPOSE This phase II trial is studying how well giving bryostatin 1 together with rituximab works in treating patients with B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia that has not responded to previous treatment with rituximab
PURPOSE This phase II trial is studying how well giving bryostatin 1 together with rituximab works in treating patients with B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia that has not responded to previous treatment with rituximab
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and safety of bryostatin 1 and rituximab in patients with rituximab-refractory indolent B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia CLL
Determine the antitumor response in patients treated with this regimen
Secondary
Determine the effects of this regimen on the functional and molecular status of effector cells ie NK cells monocytes and dendritic cells in these patients
Determine the expression of CD20 and complement-inhibitory molecules on tumor cells before and after treatment with this regimen in these patients
Determine the effects of this regimen on the global gene expression pattern in CLL cells of these patients
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV continuously over 24 hours on days -6 2 and 9 of course 1 and on days 2 and 9 of courses 2-6 Patients also receive rituximab IV over 4 hours on days 1 8 15 and 22 of courses 1 and 4 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 18-48 patients 9-24 with non-Hodgkins lymphoma and 9-24 with chronic lymphocytic leukemia will be accrued for this study within 12-30 months
Primary
Determine the feasibility and safety of bryostatin 1 and rituximab in patients with rituximab-refractory indolent B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia CLL
Determine the antitumor response in patients treated with this regimen
Secondary
Determine the effects of this regimen on the functional and molecular status of effector cells ie NK cells monocytes and dendritic cells in these patients
Determine the expression of CD20 and complement-inhibitory molecules on tumor cells before and after treatment with this regimen in these patients
Determine the effects of this regimen on the global gene expression pattern in CLL cells of these patients
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV continuously over 24 hours on days -6 2 and 9 of course 1 and on days 2 and 9 of courses 2-6 Patients also receive rituximab IV over 4 hours on days 1 8 15 and 22 of courses 1 and 4 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 18-48 patients 9-24 with non-Hodgkins lymphoma and 9-24 with chronic lymphocytic leukemia will be accrued for this study within 12-30 months
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-6216 | None | None | None |
| NIA-CII0301 | None | None | None |