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VEGF Trap in Treating Patients With Stage II or Stage III Multiple Myeloma That Has Relapsed or Not Responded to Previous Treatment

2014-08-27 03:40:04 | BioPortfolio

Summary

RATIONALE: VEGF Trap may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with stage II or stage III multiple myeloma that has relapsed or not responded to previous treatment.

Description

OBJECTIVES:

- Evaluate the safety and efficacy of VEGF Trap in patients with relapsed or refractory, stage II or III multiple myeloma.

- Evaluate the angiogenic properties of tissue for correlative studies in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically for correlative and pharmacokinetic studies. Samples are analyzed for biological markers and angiogenic profiles via immunoenzyme techniques and flow cytometry. Biomarkers may include vascular endothelial growth factor (VEGF) subtypes, platelet-derived growth factor, fibroblast growth factor, thrombopoietin, stromal-cell-derived factor, interleukin (IL)-6, IL-7, and VEGF receptor 1.

After completion of study treatment, patients are followed for 60 days and then periodically thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Intervention

aflibercept, flow cytometry, immunoenzyme technique, immunologic technique, laboratory biomarker analysis, pharmacological study

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx
New York
United States
10461

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:04-0400

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