Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005580
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2000-05-02
Brief Title:
Bryostatin Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkins Lymphoma
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I Study of Bryostatin 1 NSC 339555 and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2010-02
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed indolent non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed indolent non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the toxic effects and maximum tolerated dose of bryostatin 1 and fludarabine in patients with symptomatic or advanced chronic lymphocytic leukemia or relapsed indolent non-Hodgkins lymphoma
Monitor apoptosis differentiation and protein kinase C activity in leukemic lymphocytes exposed in vivo to bryostatin 1 and fludarabine
Observe the antitumor activity of this combination therapy in these patients
OUTLINE This is a dose-escalation multicenter study Patients are assigned to one of two treatment groups
Group I Patients receive bryostatin 1 IV over 24 hours followed by fludarabine IV over 30 minutes daily on days 1-5
Group II Patients receive fludarabine IV over 30 minutes daily on days 1-5 followed by bryostatin 1 IV over 24 hours
In both groups courses repeat every 4 weeks for patients with stable or responding disease
Cohorts of 3-6 patients receive escalating doses of fludarabine and bryostatin 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD for fludarabine is determined the dose of bryostatin 1 is escalated
PROJECTED ACCRUAL Approximately 30-60 patients will be accrued for this study within 3 years
Determine the toxic effects and maximum tolerated dose of bryostatin 1 and fludarabine in patients with symptomatic or advanced chronic lymphocytic leukemia or relapsed indolent non-Hodgkins lymphoma
Monitor apoptosis differentiation and protein kinase C activity in leukemic lymphocytes exposed in vivo to bryostatin 1 and fludarabine
Observe the antitumor activity of this combination therapy in these patients
OUTLINE This is a dose-escalation multicenter study Patients are assigned to one of two treatment groups
Group I Patients receive bryostatin 1 IV over 24 hours followed by fludarabine IV over 30 minutes daily on days 1-5
Group II Patients receive fludarabine IV over 30 minutes daily on days 1-5 followed by bryostatin 1 IV over 24 hours
In both groups courses repeat every 4 weeks for patients with stable or responding disease
Cohorts of 3-6 patients receive escalating doses of fludarabine and bryostatin 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD for fludarabine is determined the dose of bryostatin 1 is escalated
PROJECTED ACCRUAL Approximately 30-60 patients will be accrued for this study within 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 |
|---|---|---|---|
| P30CA016059 | NIH | None | None |
| MCV-CCHR-9801-2C | None | None | None |
| NCI-T97-0116 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016059 |