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



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

For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): U.S. Bioscience ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 2 Years/12 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
FeinbergJ,  Study Chair, 

United States Bioscience Inc
West Conshohocken,  Pennsylvania,  19428
United States
 


Additional Information:
Study ID Numbers:  132D;  TMTX 0015
Study Start Date: 
Record last reviewed: July 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002317

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