DISEASE CHARACTERISTICS:

• Diagnosis of bronchiolitis obliterans (BO) following allogeneic or autologous stem cell transplantation, meeting all of the following criteria:

  • FEV_1 ≤ 75% of predicted by pulmonary function test (PFT) for height and weight (if patients' pre-transplant FEV_1 was < 85%, the FEV_1 required for study entry must be at least a 10% decline from the pre-transplant value)

    • Patients must have 2 PFT measurements with documented FEV_1 values > 3 months apart to calculate the FEV_1 slope at study entry

  • Meets one of the following criteria:

    • Evidence of air-trapping or small airway thickening or bronchiectasis on high resolution chest CT scan; RV or RV/FVC > 120%; and evidence of chronic graft-vs-host disease (cGVHD) of another organ
    • FEV_1/VC (FVC or SVC, whichever is greater) ratio < 5% of predicted for age or < 0.7 (patients who smoke post-transplant must have a new decline in FEV_1 slope from a preceding slope [either from pre-transplant or sudden decline in post-transplant slope exceeding expected gradual decline from chronic obstructive pulmonary disease])
    • Pathologic evidence of bronchiolar inflammation and obstruction of the lumen consistent with a diagnosis of BO

  • No active infection

    • Any clinical symptoms must be evaluated by radiographic, microbiologic, and pathologic studies as determined by the Principal Investigator or Lead Associate Investigator

• Patients without pathologic evidence of BO must have one other sign of cGVHD present

  • For diagnosis of cGVHD, a minimum of the following must be present:

    • A process distinct from that diagnosed as acute GVHD
    • Presence of a diagnostic sign or a distinctive sign supported by another clinical or laboratory test
    • Exclusion of other pathologies (i.e., recurrent cancer, drug reaction, or infection)

• Has been on a therapeutic regimen for cGVHD for ≥ 3 months AND has stable or decreasing FEV_1

  • Any patient who has been on a therapy for cGVHD for < 3 months will need to be monitored for 3 months AND demonstrate no improvement in FEV_1 prior to study enrollment
• No tumor burden greater than minimal residual disease (i.e., tumor burden that can only be detected by molecular methods)

PATIENT CHARACTERISTICS:

• Karnofsky or Lansky performance status 40-100%
• Total bilirubin < 3 times upper limit of normal (ULN) for age
• Transaminases < 5 times ULN for age
• LVEF > 25% (for patients at NIH)
• FEV_1 ≥ 20% of predicted
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No symptoms of cardiac disease (for patients at FHCRC, JHH, or Hackensack)
• No requirement for ventilation
• No clinically significant systemic illness with manifestations of significant organ dysfunction that, in the judgment of Principal or Associate Investigator, would render the patient unlikely to tolerate study therapy or complete the study
• No history of allergy to montelukast sodium

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Any prior therapy that has been administered chronically for > 3 months for BO is allowed provided the patient has not demonstrated improvement attributed to this agent during a 1-month period (or longer) of observation prior to study enrollment

  • For patients on steroids, a change exceeding ½ mg/kg/day will be considered for the start of the 3-month monitoring period
  • Documented intercurrent infections that are treated with antimicrobials that result in improvements to, but not above, previous baselines will not be considered an improvement attributable to immunosuppressive therapy
• Prior post-transplant montelukast sodium or zafirlukast allowed provided the patient has been off treatment for at least 2 months prior to study and duration of total therapy did not exceed 3 months
• Prior bronchodilators or other pulmonary therapies allowed
• No concurrent rifampin or phenobarbital

• No concurrent ibuprofen or acetylsalicylic acid (aspirin)-containing products that inhibit cyclooxygenase except as follows:

  • Acceptable upper limit for adult daily doses of aspirin is 650 mg/day and 800 mg/day of ibuprofen
  • Acceptable upper limit for pediatric daily doses of ibuprofen is one dose per day (< 10 mg per kg to ≤ 800 mg)
• Concurrent local steroid therapy including inhaled steroid therapy during steroid taper allowed