Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT00005056
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bryostatin 1 In Treating Patients With Progressive Kidney Cancer
Sponsor:
Cancer Research UK
Organization:
Study Overview
Official Title:
A Phase II Trial of Bryostatin-1 in Hypernephroma
Status:
COMPLETED
Status Verified Date:
2006-06
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 progressive kidney cancer
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have progressive kidney cancer
Detailed Description:
OBJECTIVES: I. Determine the response rates in patients with progressive hypernephroma treated with bryostatin 1. II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. For patients with stable or responding disease after completion of course 2, treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 12-18 months.
OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. For patients with stable or responding disease after completion of course 2, treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 12-18 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: