Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390156
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2006-10-18
Brief Title:
Imatinib Bevacizumab and Cyclophosphamide in Patients With Refractory Metastatic Solid Tumors
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase I Trial of Imatinib Bevacizumab Metronomic Cyclophosphamide as Antiangiogenic Therapy in Refractory Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2020-07
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 Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Bevacizumab and cyclophosphamide may also stop the growth of tumor cells by blocking blood flow to the tumor Imatinib and bevacizumab may help cyclophosphamide work better by making tumor cells more sensitive to the drug Giving cyclophosphamide once a day together with imatinib and bevacizumab may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of imatinib when given together with bevacizumab and cyclophosphamide in treating patients with refractory metastatic solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of imatinib when given together with bevacizumab and cyclophosphamide in treating patients with refractory metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of imatinib when given together with bevacizumab and metronomic cyclophosphamide in patients with refractory metastatic solid tumors
Determine the safety profile of this regimen in these patients
Secondary
Determine the effects of cyclophosphamide and bevacizumab on imatinib pharmacokinetics
Determine if patients treated with this regimen achieve plasma levels of cyclophosphamide that are predicted to be antiangiogenic
Determine the effects of this regimen on the number of circulating endothelial cells endothelial progenitor cells activated endothelial cells and circulating tumor cells
Determine the effects of this regimen on parameters measured by CT scan perfusion eg regional blood flow blood volume permeability-surface area product and mean transit time
OUTLINE This is a nonrandomized open-label pilot dose-escalation study of imatinib
Patients receive oral cyclophosphamide and oral imatinib once daily on days 1-28 and bevacizumab IV on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib 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 At least 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of imatinib when given together with bevacizumab and metronomic cyclophosphamide in patients with refractory metastatic solid tumors
Determine the safety profile of this regimen in these patients
Secondary
Determine the effects of cyclophosphamide and bevacizumab on imatinib pharmacokinetics
Determine if patients treated with this regimen achieve plasma levels of cyclophosphamide that are predicted to be antiangiogenic
Determine the effects of this regimen on the number of circulating endothelial cells endothelial progenitor cells activated endothelial cells and circulating tumor cells
Determine the effects of this regimen on parameters measured by CT scan perfusion eg regional blood flow blood volume permeability-surface area product and mean transit time
OUTLINE This is a nonrandomized open-label pilot dose-escalation study of imatinib
Patients receive oral cyclophosphamide and oral imatinib once daily on days 1-28 and bevacizumab IV on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib 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 At least 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| CSTI571BUS245 | OTHER | Novartis | None |
| 06991 | OTHER | None | None |
| H9672-28868 | OTHER | None | None |