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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trimetrexate glucuronate

Leucovorin calcium

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

United States Bioscience Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002317

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

U.S. Bioscience

1. Study Identification

Unique Protocol Identification Number

NCT00002317

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 1993

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

U.S. Bioscience

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Pneumocystis Carinii, HIV Infections

Keywords

Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Trimetrexate glucuronate

Intervention Type

Drug

Intervention Name(s)

Leucovorin calcium

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Feinberg J

Official's Role

Study Chair

Facility Information:

Facility Name

United States Bioscience Inc

City

West Conshohocken

State/Province

Pennsylvania

ZIP/Postal Code

19428

Country

United States

Pneumonia, Pneumocystis Carinii, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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