Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003968
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Bryostatin-1 in Metastatic Renal Cell CarcinomaSummary Last Modified 81999
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:
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 |
|---|---|---|---|
| CDR0000067169 | REGISTRY | PDQ Physician Data Query | None |
| FCCC-99012 | None | None | None |
| NCI-T99-0002 | None | None | None |