Trial | NCT00002317  Report issue

Title

A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
A Study of Neutrexin (Trimetrexate Glucuronate) With Leucovorin Protection for Pediatric Patients (Ages 2-12) With Pneumocystis Carinii Pneumonia

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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).
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.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Trimetrexate glucuronate

Drug Leucovorin calcium

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.
No Results Posted