Clinical trial: Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients (NCT00003938)

Eligibility criteria:
DISEASE CHARACTERISTICS:

          -  Hematologic malignancy or solid tumor

          -  Must be undergoing remission induction and/or consolidation therapy for hematologic
             malignancy only OR

          -  Must be undergoing allogeneic or autologous bone marrow transplantation

          -  Granulocyte count less than 500/mm^3 and profound granulocytopenia expected to last
             for greater than 5 days

          -  Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than
             84 hours to broad spectrum antimicrobials, after exclusion of current bacterial,
             fungal, viral, parasitic, and mycobacterial infections

          -  Peripheral blood cultures and central venous catheter cultures negative for infections

          -  No microbiological documentation of a bacterial infection (e.g., abscess at catheter
             site)

          -  No invasive fungal infection

          -  No probable noninfectious cause of fever

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  Karnofsky 40-100% OR

          -  WHO 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  See Disease Characteristics

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  No prior anaphylactic reaction to amphotericin B

          -  No psychological, familial, sociological, or geographical conditions that would
             prevent compliance

          -  Not pregnant or nursing

          -  Normal chest X-ray or normal high resolution CT scan of the lungs

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Disease Characteristics

        Chemotherapy:

          -  See Disease Characteristics

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  Not specified

        Surgery:

          -  Not specified

        Other:

          -  No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g.,
             azoles or polyenes)

          -  No prior IV amphotericin B during same neutropenic episode

          -  No change in antibacterial regimen within 48 hours prior to study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment