Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004008
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer
Sponsor:
University of Glasgow
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion
Status:
COMPLETED
Status Verified Date:
1999-11
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
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES
Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV over 24 hours Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable or regressive disease may receive additional treatment
Patients are followed for at least 4 weeks after treatment then every 3 months
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV over 24 hours Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable or regressive disease may receive additional treatment
Patients are followed for at least 4 weeks after treatment then every 3 months
PROJECTED ACCRUAL A total of 14-25 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-T99-0027 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067219 | REGISTRY | None | None |