Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003936
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
1999-11-01
Brief Title:
Bryostatin 1 in Treating Patients With Recurrent or Refractory Hodgkins Disease
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 Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2014-04
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 who have recurrent or refractory Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have recurrent or refractory Hodgkins disease
Detailed Description:
OBJECTIVES I Determine the response rate in patients with recurrent or refractory Hodgkins disease treated with bryostatin 1 II Determine qualitative and quantitative toxicities of bryostatin 1 in these patients III Determine duration of response and survival in these patients
OUTLINE Patients receive bryostatin 1 by continuous IV infusion over 72 hours Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity for at least 4 courses Patients who achieve complete response CR are treated with 4 additional courses beyond CR
PROJECTED ACCRUAL A total of 14-27 patients will be accrued for this study within 2 years
OUTLINE Patients receive bryostatin 1 by continuous IV infusion over 72 hours Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity for at least 4 courses Patients who achieve complete response CR are treated with 4 additional courses beyond CR
PROJECTED ACCRUAL A total of 14-27 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-C-1902 | None | None | None |
| NCI-T97-0120 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |