Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003132
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
1999-11-01
Brief Title:
Bryostatin 1 Plus Cisplatin in Treating Patients With Metastatic or Unresectable Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase I Study of Bryostatin-1 NSC 339555 and Cisplatin in Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2009-11
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 bryostatin 1 plus cisplatin in treating patients who have metastatic or unresectable cancer
PURPOSE Phase I trial to study the effectiveness of bryostatin 1 plus cisplatin in treating patients who have metastatic or unresectable cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of bryostatin 1 in combination with cisplatin in patients with advanced malignancy II Determine the recommended phase II doses of bryostatin 1 and cisplatin in both a 21 day and 14 day course based on toxicity effect on protein kinase C activity and pharmacokinetics in this patient population III Determine the pharmacokinetics of bryostatin 1 in these patients IV Identify any objective tumor responses arising from treatment in these patients
OUTLINE This is a dose escalation study of bryostatin 1 Cohorts 1-7 Patients receive cisplatin IV over 1 hour on day 1 of the first course Subsequent courses repeat every 21 days with bryostatin 1 IV over 24 hours on day 1 and cisplatin IV over 1 hour on day 2 in the absence of disease progression or unacceptable toxicity Cohorts 8-10 Patients receive cisplatin as in cohorts 1-7 Subsequent courses repeat every 21 days with bryostatin 1 IV over 1 hour followed by cisplatin on day 1 Cohort 11 Patients receive bryostatin 1 and cisplatin as in cohorts 8-10 Cohorts of 3-6 patients receive escalating doses of bryostatin 1 or cisplatin until the maximum tolerated dose MTD of is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT The recommended phase II dose RPTD is defined as the dose preceding the MTD After the RPTD is determined for the 21 day schedule cohorts of patients receive escalating doses of bryostatin and constant doses of cisplatin on a 14 day schedule The MTD14 and RPTD14 are determined in the same manner as above Patients are followed for 6 months
PROJECTED ACCRUAL A total of 36-72 patients will be accrued for this study
OUTLINE This is a dose escalation study of bryostatin 1 Cohorts 1-7 Patients receive cisplatin IV over 1 hour on day 1 of the first course Subsequent courses repeat every 21 days with bryostatin 1 IV over 24 hours on day 1 and cisplatin IV over 1 hour on day 2 in the absence of disease progression or unacceptable toxicity Cohorts 8-10 Patients receive cisplatin as in cohorts 1-7 Subsequent courses repeat every 21 days with bryostatin 1 IV over 1 hour followed by cisplatin on day 1 Cohort 11 Patients receive bryostatin 1 and cisplatin as in cohorts 8-10 Cohorts of 3-6 patients receive escalating doses of bryostatin 1 or cisplatin until the maximum tolerated dose MTD of is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT The recommended phase II dose RPTD is defined as the dose preceding the MTD After the RPTD is determined for the 21 day schedule cohorts of patients receive escalating doses of bryostatin and constant doses of cisplatin on a 14 day schedule The MTD14 and RPTD14 are determined in the same manner as above Patients are followed for 6 months
PROJECTED ACCRUAL A total of 36-72 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 |
|---|---|---|---|
| NYU-9709 | None | None | None |
| NCI-T97-0058 | None | None | None |