Overview

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

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

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).

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

U.S. Bioscience

Treatments:

Calcium
Leucovorin
Levoleucovorin
Trimetrexate

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.