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

U.S. Bioscience

Overview

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).

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Pneumonia, Pneumocystis Carinii HIV Infections

Interventions

Trimetrexate glucuronateDRUG

Leucovorin calciumDRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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. * 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.

Locations (1)

United States Bioscience Inc

West Conshohocken, Pennsylvania, United States

Data from ClinicalTrials.gov

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