Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017342
Status:
COMPLETED
Last Update Posted:
2010-03-01
First Post:
2001-06-06
Brief Title:
Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase II Study Of Bryostatin 1 NSC 339555 And High-Dose 1-B-D-Arabinofuranosylcytosine HiDAC In Patients With Refractory Leukemia
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 II trial to study the effectiveness of combining bryostatin 1 with cytarabine in treating patients who have relapsed primary acute myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of combining bryostatin 1 with cytarabine in treating patients who have relapsed primary acute myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the response rate in patients with primary acute myelogenous leukemia in first relapse treated with bryostatin 1 and high-dose cytarabine
Determine the toxic effects of this regimen in these patients
Determine the relapse-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Induction Patients receive bryostatin 1 IV over 24 hours on days 1 and 11 Patients also receive high-dose cytarabine IV over 3 hours every 12 hours for 4 infusions on days 2-3 and days 9-10
Patients who achieve a major response receive a second course of induction therapy
Consolidation Patients who achieve complete remission receive bryostatin 1 IV over 24 hours on days 1 and 10 and high-dose cytarabine IV over 3 hours every 12 hours for 2 infusions on days 2 and 9 Treatment continues for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients who achieve a response and subsequently relapse may receive additional induction and consolidation therapy at the discretion of the investigator
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 15-46 patients will be accrued for this study
Determine the response rate in patients with primary acute myelogenous leukemia in first relapse treated with bryostatin 1 and high-dose cytarabine
Determine the toxic effects of this regimen in these patients
Determine the relapse-free survival and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Induction Patients receive bryostatin 1 IV over 24 hours on days 1 and 11 Patients also receive high-dose cytarabine IV over 3 hours every 12 hours for 4 infusions on days 2-3 and days 9-10
Patients who achieve a major response receive a second course of induction therapy
Consolidation Patients who achieve complete remission receive bryostatin 1 IV over 24 hours on days 1 and 10 and high-dose cytarabine IV over 3 hours every 12 hours for 2 infusions on days 2 and 9 Treatment continues for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients who achieve a response and subsequently relapse may receive additional induction and consolidation therapy at the discretion of the investigator
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 15-46 patients will be accrued for this study
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-4710 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016059 |
| P30CA016059 | NIH | None | None |
| MCV-MCC-4710 | None | None | None |