A Study of Neutrexin Plus Leucovorin in the Treatment of NCT00002434

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002434
Other study ID #	132A
Secondary ID	TMTX 0014
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 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).

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.

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	2 Years and older
Eligibility	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.

Study Design

Endpoint Classification: Safety Study, 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 Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)

Clinical Trial Details — Status: Completed

Administrative data

Study information