Infliximab in Treating Patients With Myelodysplastic Syndrome

DISEASE CHARACTERISTICS:

* Confirmed diagnosis (within the past month) of low- or intermediate-risk myelodysplastic syndromes (MDS) meeting all of the following criteria:

  * No more than 10% bone marrow blasts (corresponding to refractory anemia \[RA\], RA with ringed sideroblasts, or RA with excess blasts)
  * Meets at least 1 of the following hematopoietic criteria:

    * Hemoglobin no greater than 10 g/dL OR red blood cell transfusion dependent
    * Neutrophil count no greater than 1,500/mm\^3
    * Platelet count no greater than 100,000/mm\^3 OR platelet transfusion dependent
  * No poor cytogenetics (complex abnormalities or involvement of chromosome 7)

    * Patients with unknown cytogenetics may be eligible provided reasonable efforts have been made for determining the cytogenetic profile and the results are considered a failure (e.g., normal karyotype \[NN\] with no more than 10 metaphases)

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics

Hepatic

* No history of documented hepatitis C
* No documented active hepatitis B
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT less than 2.5 times ULN

Renal

* Creatinine less than 1.5 times ULN

Cardiovascular

* No New York Heart Association class III or IV heart disease
* No clinical history or evidence of congestive heart failure
* No severe cardiac dysfunction
* LVEF greater than 35%

Pulmonary

* No prior or concurrent active or latent tuberculosis (TB)

  * No evidence of prior or concurrent active TB (i.e., fibrotic or pleural scarring, pulmonary nodules, mediastinal and/or hilar lymphadenopathy, upper lobe volume loss, or cavitation) by chest x-ray
  * Negative intradermal tuberculin skin test (i.e., induration less than 5 mm)
* No severe pulmonary dysfunction

Immunologic

* No prior or concurrent opportunistic infection (e.g., herpes zoster, cytomegalovirus, Pneumocystic carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within the past 6 months
* No concurrent severe (CTC grade III or IV) active, chronic, or recurrent infections
* No recent history of allergies
* HIV negative

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No prior clinically significant adverse event to murine or chimeric proteins or human/murine recombinant products
* No recent contact with an individual with active TB
* No poor medical risk due to other systemic disease
* No multiple sclerosis or other demyelinating disorder
* No peripheral neuropathy greater than CTC grade 1
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior infliximab or other monoclonal antibodies
* At least 6 weeks since prior hematopoietic growth factors for MDS
* At least 3 months since prior therapy targeted at reducing tumor necrosis factor (TNF) alpha (e.g., pentoxifylline, thalidomide, or etanercept)
* No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
* No other concurrent drugs targeted at reducing TNF alpha (e.g., pentoxifylline, thalidomide, or etanercept)

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No prior solid organ transplantation

  * Corneal transplantation more than 3 months ago allowed

Other

* No prior randomization to this clinical trial
* At least 6 weeks since prior treatment for MDS (except supportive care)
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent therapeutic-dose nonsteroidal anti-inflammatory drugs (NSAIDs)

  * Concurrent sporadic (no more than 3 tablets/week) over-the-counter NSAIDs allowed
* Concurrent cardioprotective doses (80 mg/day or equivalent) of aspirin allowed