Bevacizumab in Treating Patients With Myelodysplastic Syndrome

Not Recruiting

Trial ID: NCT00022048


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.

Official Title

Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)

Stanford Investigator(s)

Peter Greenberg
Peter Greenberg

Professor of Medicine (Hematology), Emeritus



* Histologically confirmed myelodysplastic syndrome (MDS)

* Refractory anemia (RA)
* RA with excess blasts (RAEB)
* RAEB in transformation
* RA with ringed sideroblasts
* Non-proliferative chronic myelomonocytic leukemia (WBC less than 12,000/mm\^3)
* At least 1 of the following cytopenias:

* Untransfused hemoglobin no greater than 10.0 g/dL and/or red cell transfusion dependent
* Absolute neutrophil count no greater than 1,800/mm\^3 (neutropenia)
* Platelet count no greater than 100,000/mm\^3 (thrombocytopenia)
* No secondary MDS
* No known brain metastases



* 18 and over

Performance status:

* ECOG 0-2
* Karnofsky 60-100%

Life expectancy:

* More than 4 months


* See Disease Characteristics
* Platelet count at least 20,000/mm\^3
* No hemorrhagic illness within the past 3 weeks
* No hemolysis
* No iron deficiency
* No active blood loss


* AST and ALT no greater than 2.5 times upper limit of normal (ULN)
* Bilirubin no greater than 2.0 mg/dL
* INR less than 2.0
* PTT less than 1.5 times ULN


* Creatinine no greater than 2.0 mg/dL
* No renal dysfunction requiring dialysis within the past 6 months
* No nephrotic syndrome within the past 6 months


* No myocardial infraction within the past 6 months
* No severe or unstable angina within the past 6 months
* No severe peripheral vascular disease (ischemic rest pain, non-healing wound or ulcer, or tissue loss) within the past 6 months
* No uncontrolled hypertension within the past 6 months
* No transient ischemic attack within the past 6 months
* No cerebrovascular accident within the past 6 months
* No deep venous or arterial thrombosis
* No coronary artery disease
* No symptomatic congestive heart failure (New York Heart Association class II-IV heart disease)
* No cardiac arrhythmia
* No vascular illness within the past 3 weeks


* No pulmonary embolism


* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other active malignancy except localized squamous cell or basal cell skin cancer

* Prior cured malignancy allowed
* No trauma within the past 3 weeks
* No significant inflammatory disease within the past 3 weeks
* No serious non-healing wound, ulcer, or bone fracture
* No hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
* No other active severe disease
* No infection
* No psychiatric illness or social situation that would preclude study compliance
* HIV negative


Biologic therapy:

* No prior allogeneic bone marrow transplantation
* At least 30 days since prior biologic response modifiers
* At least 30 days since prior hematopoietic growth factors
* At least 30 days since prior thalidomide
* No concurrent thalidomide
* No other concurrent biologic response modifiers
* No concurrent hematopoietic growth factors (including epoetin alfa)
* Concurrent filgrastim (G-CSF) for febrile neutropenia allowed
* Concurrent transfusions allowed


* At least 30 days since prior chemotherapy
* No concurrent chemotherapy

Endocrine therapy:

* No concurrent corticosteroid therapy (more than 10 mg/day of prednisone or equivalent steroid dose) except for pre-medication for transfusions


* At least 30 days since prior radiotherapy
* No concurrent radiotherapy


* At least 3 weeks since prior surgery (including biopsy of visceral organ)


* At least 10 days since prior anticoagulants
* No concurrent cytotoxic agents
* No other concurrent investigational agents


biological: bevacizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305