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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Pneumonia, Pneumocystis Carinii HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Trimetrexate glucuronate

Intervention Type DRUG

Leucovorin calcium

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Feinberg J

Role: STUDY_CHAIR

Locations

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United States Bioscience Inc

West Conshohocken, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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TMTX 0015

Identifier Type: -

Identifier Source: secondary_id

132D