Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
About this trial
This is an interventional treatment trial for Leukemia focused on measuring refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, refractory anemia, previously treated myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of primary or secondary (therapy-related) myelodysplastic syndromes* (MDS), including the following cellular types: Refractory anemia (RA)** RA with excess blasts (RAEB)-1 RA with ringed sideroblasts** Refractory cytopenia with multilineage dysplasia Refractory cytopenia with multilineage dysplasia with ringed sideroblasts* MDS-unclassified** MDS associated with isolated del (5q)** Chronic myelomonocytic leukemia (CMML)-1 NOTE: *High-risk MDS (i.e., RAEB-2 or CMML-2) is closed to accrual as of 11/30/06 NOTE: **Accompanied with at least 1 of the following laboratory values: hemoglobin less than 10 g/dL, platelet count less than 50,000/mm3, or absolute neutrophil count less than 1,000/mm3 No prior leukemia (i.e., 20% or greater blasts) No prior primary or metastatic brain tumor or carcinomatous meningitis PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN APTT no greater than 1.5 times ULN INR no greater than 1.5 Renal Creatinine no greater than 1.5 times ULN Urine protein negative by urinalysis Protein 1+ by dipstick allowed provided total urine protein no greater than 500 mg AND creatinine clearance at least 50 mL/min by 24-hour urine collection Cardiovascular No significant cardiac or vascular events within the past 6 months, including any of the following: Acute myocardial infarction Unstable angina Uncontrolled hypertension Severe peripheral vascular disease (e.g., ischemic pain at rest or nonhealing ulcers or wounds) New York Heart Association class II-IV congestive heart failure Cardiac arrhythmia Disseminated intravascular coagulation or other coagulopathies Deep vein or arterial thrombosis No history of congenital long QTc syndrome or elongated QTc (> 450 msec for males or 470 for females) Pulmonary No pulmonary embolism within the past 6 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 3 months after study participation No need for full anticoagulation within the past 6 months No significant hemorrhage (e.g., visceral, gastrointestinal, genitourinary, or gynecological) requiring red blood cell transfusion within the past month No known cerebral aneurysms, other cerebrovascular malformations, or CNS bleeding No unhealed fractures, wounds, or ulcers PRIOR CONCURRENT THERAPY: Biologic therapy More than 12 months since prior autologous stem cell or allogeneic transplantation More than 6 months since prior antiangiogenic agents More than 1 month since prior interferon for MDS More than 1 month since prior hematopoietic growth factors for MDS More than 1 month since prior epoetin alfa (EPO) for MDS More than 1 month since prior thalidomide for MDS More than 1 month since prior immunotherapy for MDS No concurrent prophylactic growth factors or cytokines (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], EPO or EPO-derivatives, or interleukin-11) Chemotherapy No prior low-dose antimetabolites for MDS (e.g., hydroxyurea, azacitidine, or low-dose cytarabine) More than 12 months since prior chemotherapy for another disease* NOTE: *Not MDS or leukemia Endocrine therapy More than 1 month since prior corticosteroids for MDS More than 1 month since prior androgens for MDS Radiotherapy More than 12 months since prior radiotherapy for another disease* NOTE: *Not MDS or leukemia Surgery More than 1 month since prior surgery, including needle biopsy of visceral organs and recovered Bone marrow biopsy allowed More than 2 weeks since prior placement of a subcutaneous or tunneled venous access device (e.g., PortaCath or Hickman's catheter) and adequately healed Other No prior cytotoxic therapy for MDS More than 1 month since prior administration of any of the following medications for MDS: Danazol Retinoids Amifostine Investigational agents No concurrent administration of any of the following medications: Warfarin Heparin Derivatives of heparin Other anticoagulants No concurrent grapefruit or grapefruit juice
Sites / Locations
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Evanston Northwestern Healthcare - Evanston Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- Center for Cancer Care at OSF Saint Anthony Medical Center
- St. Margaret's Hospital
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
- Union Hospital Cancer Program at Union Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- CCOP - Kansas City
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Callahan Cancer Center at Great Plains Regional Medical Center
- CCOP - Missouri Valley Cancer Consortium
- Methodist Estabrook Cancer Center
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- Roswell Park Cancer Institute
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Long Island Jewish Medical Center
- Mount Sinai Medical Center
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Faxton Regional Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Comprehensive Cancer Center
- Wayne Memorial Hospital, Incorporated
- Pardee Memorial Hospital
- Kinston Medical Specialists
- Wake Forest University Comprehensive Cancer Center
- Oklahoma University Cancer Institute
- Cancer Care Associates - Mercy Campus
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Rhode Island Hospital Comprehensive Cancer Center
- Miriam Hospital
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- Danville Regional Medical Center
Arms of the Study
Arm 1
Experimental
Vatalanib
Adult patients with MDS receive treatment with vatalanib.