Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

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