To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection
in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have
demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or
Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21
days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate
glucuronate. Patients are followed for 1 month.
- Myelosuppressive or nephrotoxic agents at the discretion of the treating physician.
Patients must have:
- Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
- Serious intolerance and/or resistance to standard therapies (such as
trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of
therapy for the current episode of PCP, or a documented history of such intolerance
during a prior episode.
- Consent of parent or guardian if less than 18 years of age.
- Pregnant women may enroll after the physician and patient have discussed the
potential benefit versus risk.
Patients with the following prior conditions are excluded:
History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis),
exfoliative dermatitis, or other life-threatening reactions due to trimetrexate