Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003171
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
1999-11-01
Brief Title:
Bryostatin 1 in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Clinical Evaluation of Bryostatin 1 in Patients With Myelodysplastic Syndrome
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients with myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients with myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the response rate of bryostatin 1 in patients with myelodysplastic syndrome II Determine the qualitative and quantitative toxic effects of bryostatin 1 III Determine the duration of response and survival of patients receiving this therapy
OUTLINE This is a two stage study Patients receive bryostatin 1 by continuous infusion over 72 hours every 14 days for 4 cycles Responding patients may continue treatment in the absence of disease progression or unacceptable toxicity Patients with complete response receive 2 additional cycles Patients with no response receive 4 additional cycles Patients are re-evaluated after every 4 cycles
PROJECTED ACCRUAL 14 to 27 patients will be accrued within 2 years into this 2 stage study
OUTLINE This is a two stage study Patients receive bryostatin 1 by continuous infusion over 72 hours every 14 days for 4 cycles Responding patients may continue treatment in the absence of disease progression or unacceptable toxicity Patients with complete response receive 2 additional cycles Patients with no response receive 4 additional cycles Patients are re-evaluated after every 4 cycles
PROJECTED ACCRUAL 14 to 27 patients will be accrued within 2 years into this 2 stage 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-T97-0047 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-D-1468 | None | None | None |