NCT00509249

Aflibercept in Treating Patients With Myelodysplastic Syndromes

A Phase II Study of VEGF Trap (NSC 724770) in Patients With MDS

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
BIOLOGICAL	ziv-aflibercept	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-07-31
• Last updated: 2015-01-08
• Results posted: 2015-01-08

Locations

1 site across 1 country: United States