Aflibercept in Treating Patients With Myelodysplastic Syndromes

Status Terminated

Clinical Trial Summary

This phase II trial is studying how well aflibercept works in treating patients with myelodysplastic syndromes. Aflibercept may be able to carry cancer-killing substances directly to myelodysplastic syndrome cells. It may also stop the growth of cancer cells by blocking blood flow to the cancer

Clinical Trial Description

OBJECTIVES:

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Myeloproliferative Disorders
Preleukemia
Previously Treated Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes
Syndrome

Clinical Trial Details

NCT number	NCT00509249
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Terminated
Phase	Phase 2
Start date	September 2007
Completion date	December 2010

View Details

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