Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

You may be eligible if

• 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