Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003108
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
1999-11-01
Brief Title:
Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer
Sponsor:
Lombardi Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Bryostatin and Cisplatin in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2004-07
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of cisplatin plus bryostatin 1 in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of cisplatin plus bryostatin 1 in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the dose limiting toxicity and maximum tolerated dose of combination bryostatin 1 and cisplatin chemotherapy in patients with advanced incurable solid tumors
OUTLINE This is a dose-escalation study The first 4 cohorts of patients receive an escalating dose of cisplatin with a fixed dose of bryostatin 1 followed by 5 cohorts receiving an escalating dose of bryostatin 1 and a fixed dose of cisplatin In the first course cisplatin is given as a 2 hour infusion followed by a 24 hour continuous infusion of bryostatin 1 In all subsequent courses bryostatin 1 is given first and cisplatin afterwards Treatment continues every 21 days in patients with stable or responding disease Dose escalation proceeds until the maximum tolerated dose MTD of the combination chemotherapy is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity After the MTD is determined an additional 10 patients are treated at this dose level Patients are followed at 1 month
PROJECTED ACCRUAL Approximately 24-30 patients will be accrued for this study
OUTLINE This is a dose-escalation study The first 4 cohorts of patients receive an escalating dose of cisplatin with a fixed dose of bryostatin 1 followed by 5 cohorts receiving an escalating dose of bryostatin 1 and a fixed dose of cisplatin In the first course cisplatin is given as a 2 hour infusion followed by a 24 hour continuous infusion of bryostatin 1 In all subsequent courses bryostatin 1 is given first and cisplatin afterwards Treatment continues every 21 days in patients with stable or responding disease Dose escalation proceeds until the maximum tolerated dose MTD of the combination chemotherapy is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity After the MTD is determined an additional 10 patients are treated at this dose level Patients are followed at 1 month
PROJECTED ACCRUAL Approximately 24-30 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 |
|---|---|---|---|
| CDR0000065849 | REGISTRY | None | None |
| NCI-T97-0056 | Registry Identifier | PDQ Physician Data Query | None |