Bevacizumab in Treating Patients With Myelodysplastic Syndrome

Status Completed

Clinical Trial 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 I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Leukemia
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myelodysplastic/Myeloproliferative Neoplasms
Myeloproliferative Disorders
Preleukemia
Syndrome

Clinical Trial Details

NCT number	NCT00022048
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 2001
Completion date	November 2004

View Details

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