Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-30 @ 7:21 PM
Study NCT ID:
NCT00003968
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)
Status:
COMPLETED
Status Verified Date:
2004-01
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:
Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description:
OBJECTIVES:
I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.
II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.
IV. Determine the overall survival of this patient population treated with this regimen.
OUTLINE:
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.
II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.
IV. Determine the overall survival of this patient population treated with this regimen.
OUTLINE:
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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?: