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