A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia

U.S. Bioscience

Status: Completed

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Treatments: Drug: Leucovorin calcium; Drug: Trimetrexate glucuronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002317

132D

TMTX 0015

Details and patient eligibility

About

To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric 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 parenteral pentamidine).

Full description

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.

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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.

Exclusion Criteria

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 glucuronate.