Randomized Phase II Trial With Infliximab (Remicade) in Patients With Myelodysplastic Syndrome and a Relatively Low Risk of Developing Acute Leukemia

Study start date: October 1, 2003

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