Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015951
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
2001-05-06
Brief Title:
Bevacizumab Cytarabine and Mitoxantrone on Treating Patients With Hematologic Cancers
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase II Study of the Recombinant Human Monoclonal Anti-Vascular Endothelial Growth Factor Antibody rhuMAB VEGF Bevacizumab NSC 704865 IND 7921 Administered in Times Sequential Combination With Cytosine Arabinoside Ara-C and Mitoxantrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias AMLs
Status:
COMPLETED
Status Verified Date:
2019-10
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 Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer
PURPOSE Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine the clinical effectiveness of bevacizumab cytarabine and mitoxantrone in patients with poor-risk hematologic malignancies
Determine the toxic effects of this regimen in these patients
Determine whether this regimen can induce cell apoptosis in these patients
Determine the effects of bevacizumab on coagulation profiles in these patients
OUTLINE This is a multicenter study
Patients receive cytarabine IV continuously over 72 hours on days 1-3 mitoxantrone IV over 30-60 minutes on day 4 and bevacizumab IV over 90 minutes on day 8 in the absence of disease progression or unacceptable toxicity Patients achieving partial or complete remission may receive a second course of therapy beginning approximately 30 days after the completion of the first course
Patients are followed until death
PROJECTED ACCRUAL A total of 12-45 patients will be accrued for this study within 1-3 years
Determine the clinical effectiveness of bevacizumab cytarabine and mitoxantrone in patients with poor-risk hematologic malignancies
Determine the toxic effects of this regimen in these patients
Determine whether this regimen can induce cell apoptosis in these patients
Determine the effects of bevacizumab on coagulation profiles in these patients
OUTLINE This is a multicenter study
Patients receive cytarabine IV continuously over 72 hours on days 1-3 mitoxantrone IV over 30-60 minutes on day 4 and bevacizumab IV over 90 minutes on day 8 in the absence of disease progression or unacceptable toxicity Patients achieving partial or complete remission may receive a second course of therapy beginning approximately 30 days after the completion of the first course
Patients are followed until death
PROJECTED ACCRUAL A total of 12-45 patients will be accrued for this study within 1-3 years
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-2490 | None | None | None |
| MSGCC-0076 | None | None | None |