Aflibercept in Treating Patients With Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT00509249|
Recruitment Status : Terminated (Early termination for discouraging results)
First Posted : July 31, 2007
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes||Biological: ziv-aflibercept Other: laboratory biomarker analysis Other: pharmacological study||Phase 2|
I. To determine the antitumor activity of aflibercept as assessed by the hematological response rate.
II. To determine overall and progression-free survival in patients with myelodysplastic syndromes.
III. To assess hematologic improvement and time to leukemic transformation. IV. To assess the toxicity profile of aflibercept in this patient population. V. To perform correlative studies to better understand the ability of aflibercept to reach and modulate its respective targets.
OUTLINE: This is a multicenter study.
Patients will receive aflibercept IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples will be obtained periodically for pharmacokinetic and biomarker correlative studies. Pharmacokinetic analysis by ELISA; anti-aflibercept antibody measurements; analysis of VEGF and VEGFR expression; and analysis of gene expression by quantitative PCR will be conducted. The effect of aflibercept on apoptosis and proliferation of CD34+ cells will also be analyzed by flow cytometry based assays.
After completion of study treatment, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of VEGF Trap (NSC 724770) in Patients With MDS|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Arm I
Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Other: pharmacological study
Other Name: pharmacological studies
- Hematological Response Rate [ Time Frame: Up to 3 years ]Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.0x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still > 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509249
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Mark Kirschbaum||City of Hope Medical Center|