A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in European 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).
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria
Patients must have:
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Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
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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.
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Consent of parent or guardian if less than 18 years of age.
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | United States Bioscience Inc | West Conshohocken | Pennsylvania | United States | 19428 |
Sponsors and Collaborators
- U.S. Bioscience
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 132C
- TMTX C502