A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention: Trimetrexate glucuronate (Drug); Leucovorin calcium (Drug)
Phase: N/A
Status: Completed
Sponsored by: U.S. Bioscience Official(s) and/or principal investigator(s): Feinberg J, Study Chair
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).
Clinical Details
Official title: A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia
Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
United States Bioscience Inc, West Conshohocken, Pennsylvania 19428, United States
Additional Information
Related publications: 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)
Last updated: June 23, 2005
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