Back to resultsA Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia
Primary Purpose
Pneumonia, Pneumocystis Carinii, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trimetrexate glucuronate
Leucovorin calcium
Sponsored by
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
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. Consent of parent or guardian if less than 18 years of age. 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
1. Study Identification
Unique Protocol Identification Number
NCT00002103
Brief Title
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia
Official Title
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 1994
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 European 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
13 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.
Consent of parent or guardian if less than 18 years of age.
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.
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
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A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia
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