Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136461
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2005-08-25
Brief Title:
A Study of All-Trans Retinoic Acid ATRA and Bryostatin in Patients With Acute Myeloid Leukemia AML and Myelodysplastic Syndrome MDS
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Randomized Phase II Trial of All-Trans Retinoic Acid and One of Two Schedules of Bryostatin 1 in Patients With Refractory Acute Myelogenous Leukemia AML or Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2011-03
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:
The purpose of this study is to assess the effects of the combination of all-trans retinoic acid in combination with one of two schedules of Bryostatin 1 in patients with myelodysplasia and acute myelogenous leukemia
Detailed Description:
All patients receive all-trans retinoic acid at a dose of 150 mgm2day and patients are randomized to one of two schedules of Bryostatin 1
Arm 1 Bryostatin 1 is administered at a dose of 60 mcgm2 as a 30 minute intravenous IV infusion on days 8 and 22
Arm 2 Bryostatin 1 is administered at a dose of 40 mcgm2 as a 72 hour IV infusion starting on days 8 and 22
Patients are assessed for response on day 50 with a bone marrow examination and patients with either a clinical response or stable disease receive further therapy
Bryostatin 1 pharmacokinetic samples are to be drawn on days 1 8 and 50 of each cycle
Arm 1 Bryostatin 1 is administered at a dose of 60 mcgm2 as a 30 minute intravenous IV infusion on days 8 and 22
Arm 2 Bryostatin 1 is administered at a dose of 40 mcgm2 as a 72 hour IV infusion starting on days 8 and 22
Patients are assessed for response on day 50 with a bone marrow examination and patients with either a clinical response or stable disease receive further therapy
Bryostatin 1 pharmacokinetic samples are to be drawn on days 1 8 and 50 of each cycle
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 T96-0112 | None | None | None |