Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003242
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Bryostatin 1 Plus Paclitaxel and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
An Open-Label Non-Randomized Phase I Study of the Protein Kinase C Inhibitor Bryostatin-1 Administered in Combination With Paclitaxel in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of chemotherapy with bryostatin 1 plus paclitaxel and cisplatin in treating patients with advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of chemotherapy with bryostatin 1 plus paclitaxel and cisplatin in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of intravenous bryostatin 1 when administered in combination with a fixed dose of paclitaxel and cisplatin in patients with advanced solid tumors II Investigate the clinical pharmacokinetics of intravenous paclitaxel when administered in combination with bryostatin 1 in these patients III Obtain preliminary data on the therapeutic activity of this therapy in these patients and evaluate surrogate markers of activity
OUTLINE This is an open label dose escalation study Patients receive paclitaxel IV over 1 hour on day 1 On day 2 patients receive bryostatin 1 IV over 1 hour immediately followed by cisplatin IV on day 2 Treatment is repeated weekly for 3 consecutive weeks followed by one week of rest for at least 2 courses Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are entered at escalating dose levels of bryostatin 1 and paclitaxel If 2 of 6 patients experience dose limiting toxicity DLT at any given dose level then the maximum tolerated dose MTD is declared to be the preceding dose level Once the MTD of paclitaxel and bryostatin 1 has been established escalations of weekly cisplatin will be added Additional patient cohorts receive two escalating doses of paclitaxel and cisplatin with the fixed bryostatin 1 dose level in the absence of DLT Patients at a lower bryostatin 1 dose may be escalated to a higher bryostatin 1 dose only if that higher dose has been proven to be safe in another cohort of patients
PROJECTED ACCRUAL An anticipated 3 to 60 patients will be accrued for this study within 1-14 months
OUTLINE This is an open label dose escalation study Patients receive paclitaxel IV over 1 hour on day 1 On day 2 patients receive bryostatin 1 IV over 1 hour immediately followed by cisplatin IV on day 2 Treatment is repeated weekly for 3 consecutive weeks followed by one week of rest for at least 2 courses Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are entered at escalating dose levels of bryostatin 1 and paclitaxel If 2 of 6 patients experience dose limiting toxicity DLT at any given dose level then the maximum tolerated dose MTD is declared to be the preceding dose level Once the MTD of paclitaxel and bryostatin 1 has been established escalations of weekly cisplatin will be added Additional patient cohorts receive two escalating doses of paclitaxel and cisplatin with the fixed bryostatin 1 dose level in the absence of DLT Patients at a lower bryostatin 1 dose may be escalated to a higher bryostatin 1 dose only if that higher dose has been proven to be safe in another cohort of patients
PROJECTED ACCRUAL An anticipated 3 to 60 patients will be accrued for this study within 1-14 months
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 |
|---|---|---|---|
| NCI-T97-0118 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066117 | REGISTRY | None | None |