A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)

Back to results

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 - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Myelosuppressive or nephrotoxic agents at the discretion of the treating physician. 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. NOTE: Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk. 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

NCT00002434

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

U.S. Bioscience

1. Study Identification

Unique Protocol Identification Number

NCT00002434

Brief Title

A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)

Official Title

A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia

Study Type

Interventional

2. Study Status

Record Verification Date

January 1994

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

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 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

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria Concurrent Medication: Allowed: Myelosuppressive or nephrotoxic agents at the discretion of the treating physician. 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. NOTE: Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk. 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

12. IPD Sharing Statement

Citations:

Citation

Feinberg J, McDermott C, Nutter J. Trimetrexate (TMTX) salvage therapy for PCP in AIDS patients with limited therapeutic options. Int Conf AIDS. 1992 Jul 19-24;8(2):B136 (abstract no PoB 3297)

Results Reference

background

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

Learn more about this trial