Clinical trial NCT00089141 (phase 3, status: terminated)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: mycophenolate mofetil, placebo
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    low probability of positive outcome
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed chronic-graft-versus host disease (GVHD)

          -  Systemic immunosuppressive treatment indicated AND no contraindication to treatment
             with mycophenolate mofetil

          -  Has undergone prior transplantation with any type of donor, hematopoietic stem cell
             graft, or conditioning regimen

          -  No clinical, laboratory, or image-based evidence known to be present at the time of
             enrollment and indicating a high probability of subsequent recurrent or progressive
             disease

        PATIENT CHARACTERISTICS:

        Age

          -  Any age

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Pulmonary

          -  No known bronchiolitis obliterans as a manifestation of chronic GVHD

        Immunologic

          -  No fungal infection without radiographic evidence of improvement during continued
             antifungal therapy

          -  No cytomegalovirus (CMV) pneumonia without major radiographic evidence of improvement

          -  No other CMV infection without reduction of antigenemia or viral load during continued
             antiviral therapy

          -  No active disseminated varicella zoster viral infection

          -  No known hypersensitivity or allergy to MMF

        Gastrointestinal

          -  Able to tolerate oral medication

          -  No lactose-intolerant children who are too young to swallow capsules

          -  No frank blood from the rectum

          -  No melena

          -  No known gastrointestinal ulceration

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

               -  Female patients must use 2 forms of contraception 4 weeks prior to, during, and
                  for 6 weeks after completion of study treatment

          -  Not hospitalized at time of enrollment

          -  No rare, hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase
             (HGPRT)

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Prior treatment with prednisone or equivalent allowed provided the dose was ≤ 1.0
             mg/kg/day at the time of enrollment

          -  Concurrent systemic glucocorticoids allowed

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  Prior mycophenolate mofetil (MMF) for prevention or treatment of acute GVHD allowed
             provided MMF was discontinued at least 2 weeks before the diagnosis of chronic GVHD
             was made

          -  No prior systemic treatment for chronic GVHD

          -  No prior treatment for chronic GVHD

          -  Concurrent antacids allowed provided there is at least a 2-hour interval before and
             after administration of MMF

          -  No other concurrent systemic immunosuppressive treatment except cyclosporine,
             tacrolimus or sirolimus