Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Completed no age specified NCI NCI-86-C-26 NCI-T86-0081N, T86-0081

Objectives

I.  Assess whether the immunocompromised host developing a diffuse 
interstitial pneumonitis can be successfully managed with early empiric 
antimicrobial therapy or whether specific treatment directed by the results of 
a pretherapy bronchoalveolar lavage provides better management.
II.  Assess the efficacy of bronchoalveolar lavage in establishing a diagnosis 
in untreated patients and in patients who have failed empiric therapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients who have an immunodeficiency 
or a malignant disease treated with antineoplastic drugs, corticosteroids, or 
pulmonary radiation and who develop a diffuse pneumonitis or hypoxia of 
unknown etiology (hypoxia defined as a corrected PaO2 less than 70 mm Hg or a 
decrease in PaO2 of 15% compared to a previously abnormal baseline).  Patients 
with acquired immune deficiency syndrome (AIDS) are not eligible.  Patients 
are not eligible if the cause of the pneumonitis or hypoxia is known with 
certainty; patients determined to have radiation-induced pneumonitis as a 
result of pulmonary radiation are not eligible.  Patients may not be receiving 
treatment with the prophylactic antibiotics trimethoprim-sulfamethoxazole.  
Patients who are too thrombocytopenic for bronchoalveolar lavage (i.e., 
platelets not corrected to above 30,000/cumm) or who are deemed too unstable 
for the lavage procedure (i.e., non-intubated patients must have an arterial 
PO2 of at least 75 torr on supplemental oxygen; intubated patients must have 
positive-end expiratory pressures of no more than 10 cm H2O) are ineligible 
for randomization, as are patients with disseminated Varicella-Zoster 
infection.

Expected Enrollment

104 patients/arm will be required.

Outline

Randomized study.
Arm I:  Empiric Antibiotic Therapy.  Trimethoprim-Sulfamethoxazole, TMP-SMX; 
Erythromycin; plus (as indicated) Ceftazidime; Vancomycin; Gentamycin; 
Piperacillin; Amphotericin B.
Arm II:  Bronchoscopy plus Empiric or Specific Antibiotic Therapy.  
Bronchoalveolar lavage; plus TMP-SMX; Erythromycin; plus specific antibiotics 
as indicated by results of lavage.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Philip Pizzo, MD, Protocol chair		Ph: 650-724-5688 Email: philip.pizzo@stanford.edu