A Compassionate Treatment Protocol for the Use of NCT00002102

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002102
Other study ID #	132B
Secondary ID	TMTX C010
Status	Completed
Phase	N/A
First received	November 2, 1999
Last updated	June 23, 2005

Study information
Verified date	January 1994
Source	NIH AIDS Clinical Trials Information Service
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial Summary

To provide trimetrexate glucuronate to immunosuppressed patients with Pneumocystis carinii pneumonia (PCP) for whom this investigational compound could provide significant medical benefit.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral therapy (at the discretion of the treating physician and/or medical monitor). Patients must have: - Presumptive or definitive diagnosis of Pneumocystis carinii pneumonia (PCP). - HIV positivity or be otherwise immunosuppressed. - Demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, OR a documented history of such intolerance during a prior episode. - Consent of parent or guardian if less than 18 years of age. NOTE: - In general, patients who meet the eligibility criteria for other U.S. Bioscience-sponsored clinical trials for trimetrexate would not be eligible for this Compassionate Use protocol. 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 to trimetrexate.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Trimetrexate glucuronate

• Leucovorin calcium

Locations
Country	Name	City	State
United States	United States Bioscience Inc	West Conshohocken	Pennsylvania

Sponsors *(1)*
Lead Sponsor	Collaborator
U.S. Bioscience

Country where clinical trial is conducted

United States,

References & Publications (1)

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)

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A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia.

Clinical Trial Details — Status: Completed

Administrative data

Study information