Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-26 @ 4:49 PM
Study NCT ID:
NCT00015951
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
2001-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
Sponsor:
University of Maryland, Baltimore
Organization:
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 # 7,921) 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: