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Home > "B" Clinical Trials Conditions > Bevacizumab in Treating Patients With Myelodysplastic Syndrome  Bevacizumab in Treating Patients With Myelodysplastic Syndrome
Bevacizumab in Treating Patients With Myelodysplastic Syndrome
For Condition: myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia,Chronic Myelomonocytic Leukemia,Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): Stanford University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of bevacizumab in treating patients who have myelodysplastic syndrome.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterGreenberg, Study Chair, Stanford University
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Jorge Cortes 713-794-5783
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Alan List 520-626-2340
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5750
United States
Recruiting Peter Greenberg 650-725-8355
Additional Information:
Study ID Numbers: CDR0000068778; SUMC-NCI-2771,NCI-2771
Study Start Date:
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022048
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
2. MS-275 in Treating Patients With Hematologic Cancer
3. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
4. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
5. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bevacizumab in Treating Patients With Myelodysplastic Syndrome
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