Bevacizumab in Treating Patients With Myelodysplastic Syndrome

NCT00022048 | Completed Phase 1

• 4 other identifiers: SUMC-MDA-ID-01152CDR0000068778MDA-ID-01152NCI-2771
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Keywords

refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; myelodysplastic/myeloproliferative neoplasm, unclassifiable; atypical chronic myeloid leukemia, BCR-ABL1 negative

Interventions

bevacizumab BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305-5750, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic; Myeloproliferative Disorders; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Peter L. Greenberg, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Study Completion: November 1, 2004
• Last Updated: May 15, 2013

Record last verified: 2004-10

Locations

US (3)