Trial Search Results

Bevacizumab in Treating Patients With Myelodysplastic Syndrome

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: bevacizumab

Phase:

Phase 1/Phase 2

Eligibility


DISEASE CHARACTERISTICS:

   - 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

PATIENT CHARACTERISTICS:

Age:

   - 18 and over

Performance status:

   - ECOG 0-2

   - Karnofsky 60-100%

Life expectancy:

   - More than 4 months

Hematopoietic:

   - 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

Hepatic:

   - 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

Renal:

   - 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

Cardiovascular:

   - 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

Pulmonary:

   - No pulmonary embolism

Other:

   - 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

   - 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

Radiotherapy:

   - At least 30 days since prior radiotherapy

   - No concurrent radiotherapy

Surgery:

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

Other:

   - At least 10 days since prior anticoagulants

   - No concurrent cytotoxic agents

   - No other concurrent investigational agents

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

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