Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112476
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2005-06-02
Brief Title:
Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Intravenous CCI-779 in Combination With Bryostatin-1 in Solid Tumors 10038414
Status:
COMPLETED
Status Verified Date:
2013-05
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:
This phase I trial is studying the side effects and best dose of temsirolimus when given together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors Drugs used in chemotherapy such as temsirolimus and bryostatin 1 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of temsirolimus when given together with bryostatin 1 in patients with unresectable or metastatic solid tumors
II Determine the dose-limiting toxic effects of this regimen in these patients
SECONDARY OBJECTIVES
I Correlate the extent and duration of inhibition of p70S6kinase phosphorylation in peripheral blood mononuclear cells with tumor growth or reduction in these patients
II Correlate the phosphorylation total and phospho-AKT and total and phospho ribosomal S6 protein indicators of mTOR activation with antitumor effects of this regimen in these patients
III Correlate tumor expression of phospho-ERK1 and -ERK2 with antitumor effects of this regimen in these patients
IV Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of temsirolimus
Patients receive bryostatin 1 IV over 1 hour on days 1 8 15 and 22 and temsirolimus IV over 30 minutes once on days 8 15 and 22 during course 1 On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
I Determine the maximum tolerated dose and recommended phase II dose of temsirolimus when given together with bryostatin 1 in patients with unresectable or metastatic solid tumors
II Determine the dose-limiting toxic effects of this regimen in these patients
SECONDARY OBJECTIVES
I Correlate the extent and duration of inhibition of p70S6kinase phosphorylation in peripheral blood mononuclear cells with tumor growth or reduction in these patients
II Correlate the phosphorylation total and phospho-AKT and total and phospho ribosomal S6 protein indicators of mTOR activation with antitumor effects of this regimen in these patients
III Correlate tumor expression of phospho-ERK1 and -ERK2 with antitumor effects of this regimen in these patients
IV Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a dose-escalation study of temsirolimus
Patients receive bryostatin 1 IV over 1 hour on days 1 8 15 and 22 and temsirolimus IV over 30 minutes once on days 8 15 and 22 during course 1 On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| CDR0000432955 | None | None | None |
| 04-037 | None | None | None |
| FCCC-04037 | None | None | None |
| NCI-5785 | None | None | None |