Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022048
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2001-08-10
Brief Title:
Bevacizumab in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Stanford University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Safety and Efficacy Trial of Bevacizumab Anti-VEGF Humanized Monoclonal Antibody NSC 704865 Therapy for Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2004-10
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 block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them
PURPOSE This phase III trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome
PURPOSE This phase III trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the hematologic responses including changes in hemoglobin levels neutrophil counts platelet counts and percentage of bone marrow blasts in patients with myelodysplastic syndrome treated with bevacizumab
Determine the toxic effects of this regimen in these patients
Determine the tolerance in patients treated with this regimen
Determine bone marrow cytogenetic responses in patients treated with this regimen
Determine bone marrow microvessel density in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to International Prognostic Scoring System risk status low low or intermediate-1 vs high intermediate-2 or high
Patients receive bevacizumab IV over 30-90 minutes Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity
Patients are followed at weeks 1 3 5 7 and 9
PROJECTED ACCRUAL A total of 16-25 patients will be accrued for this study within 2 years
Determine the hematologic responses including changes in hemoglobin levels neutrophil counts platelet counts and percentage of bone marrow blasts in patients with myelodysplastic syndrome treated with bevacizumab
Determine the toxic effects of this regimen in these patients
Determine the tolerance in patients treated with this regimen
Determine bone marrow cytogenetic responses in patients treated with this regimen
Determine bone marrow microvessel density in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to International Prognostic Scoring System risk status low low or intermediate-1 vs high intermediate-2 or high
Patients receive bevacizumab IV over 30-90 minutes Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity
Patients are followed at weeks 1 3 5 7 and 9
PROJECTED ACCRUAL A total of 16-25 patients will be accrued for this study within 2 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2771 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068778 | REGISTRY | None | None |
| MDA-ID-01152 | None | None | None |